Techniques for deployment of a prosthetic valve

- CARDIOVALVE LTD.

A method includes percutaneously advancing an implant to a native heart valve of a subject, the implant being housed in a compressed state within a delivery tool. Next, the method includes unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant. Subsequently, the longitudinally-proximal portion of the implant is unhoused. Subsequently, the longitudinally-distal portion of the implant is unhoused. By unhousing flanges of the implant, the flanges automatically expand. Upon the flanges expanding, a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction. Other applications are also described.

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Description
CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation application of U.S. patent application Ser. No. 15/668,659, filed Aug. 3, 2017, entitled, “Techniques for deployment of a prosthetic valve,” which issued as U.S. Pat. No. 10,918,481 and which:

    • (1) is a Continuation-In-Part of PCT application IL2016/050125, filed Feb. 3, 2016, entitled “Prosthetic valve with axially-sliding frames,” which published as WO 2016/125160, and which claims priority from U.S. Provisional Patent Application 62/112,343 to Hariton et al., filed Feb. 5, 2015, and entitled “Prosthetic valve with axially-sliding frames”; and
    • (2) is a Continuation-In-Part of U.S. patent application Ser. No. 15/541,783, entitled “Prosthetic valve with axially-sliding frames,” which issued as U.S. Pat. No. 9,974,651, and which is the US National Phase of PCT application IL2016/050125, filed Feb. 3, 2016, entitled “Prosthetic valve with axially-sliding frames,” which published as WO 2016/125160, and which claims priority from U.S. Provisional Patent Application 62/112,343 to Hariton et al., filed Feb. 5, 2015, and entitled “Prosthetic valve with axially-sliding frames.”

All of the above applications are incorporated herein by reference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to valve replacement. More specifically, some applications of the present invention relate to prosthetic valves for replacement of a cardiac valve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the ventricle that is present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the valve annulus.

Dilation of the annulus of the valve prevents the valve leaflets from fully coapting when the valve is closed. Regurgitation of blood from the ventricle into the atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the ventricle secondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some applications, an implant is provided having a tubular portion, an upstream support portion and one or more flanges. The implant is percutaneously deliverable to a native heart valve in a compressed state, and is expandable at the native valve. The implant and its delivery system facilitate causing the upstream support portion and the flanges to protrude radially outward from the tubular portion without expanding the tubular portion. Expansion of the tubular portion brings the upstream support portion and the flanges closer together, for securing the implant at the native valve by sandwiching tissue of the native valve between the upstream support portion and the flanges.

For some applications, a delivery tool is provided, including a delivery capsule, disposed at a distal portion of the tool. The delivery capsule includes a proximal capsule-portion dimensioned to house a first part of an implant, and a distal capsule-portion dimensioned to house a second part of the implant; and an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion including one or more controllers and one or more locks. The controllers are operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers. The tool has sequential states in which movement of the proximal and distal capsule-portions is variously inhibited or facilitated. For some applications, in response to a movement of a capsule-portion that is facilitated in a given state, the tool unlocks the subsequent state.

There is therefore provided, in accordance with an application of the present invention, apparatus including an implant and a delivery tool, the tool including:

a delivery capsule, disposed at a distal portion of the tool, the delivery capsule including a proximal capsule-portion dimensioned to house a first part of the implant, and a distal capsule-portion dimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion including one or more controllers and one or more locks, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers,

and the controllers and the locks are mechanically cooperative such that:

    • in a state A of the tool:
      • a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated,
      • a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited, and
      • a proximal movement of the proximal capsule-portion proximally with respect to the implant is facilitated; and
    • in a state B of the tool:
      • the second distal movement of the distal capsule-portion is facilitated.

In an application, in the state A, a lock of the one or more locks is locked, and unlocking of the lock transitions the tool into the state B.

In an application, the lock is not unlockable until the distal capsule-portion has been moved the first distance distally with respect to the implant.

In an application, the lock is not unlockable until the proximal capsule-portion has been moved proximally with respect to the implant.

In an application:

the one or more controllers include a first controller and a second controller, and

in the state A, actuation of the first controller causes the first distal movement of the distal capsule-portion, and actuation of the second controller causes the proximal movement of the proximal capsule-portion.

In an application, in the state B, further actuation of the first controller causes the second distal movement of the distal capsule-portion.

In an application, the one or more controllers further include a third controller, and, in the state B, actuation of the third controller causes the second distal movement of the distal capsule-portion.

In an application, the implant is for use at a native mitral valve of a subject, and:

the first part of the implant includes an upstream support portion, configured to be placed against an upstream surface of the native mitral valve,

the second part of the implant includes a downstream end of the implant, and a plurality of flanges (i) disposed longitudinally between the upstream support portion and the downstream end, and (ii) configured to engage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the plurality of flanges, but not the downstream end of the implant.

In an application, the implant is housed by the delivery capsule such that the second distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the downstream end of the implant.

In an application, the implant is housed by the delivery capsule such that the proximal movement of the proximal capsule-portion unhouses, from the proximal capsule-portion, the upstream support portion.

In an application, the implant includes:

a valve frame that includes:

    • a tubular portion shaped to define a lumen therethrough, and
    • the upstream support portion, extending from an upstream end of the tubular portion;

an outer frame that circumscribes the tubular portion, and includes the plurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portion within the lumen.

In an application, the second part of the implant includes at least part of the tubular portion.

There is further provided, in accordance with an application of the present invention, apparatus including an implant and a delivery tool, the tool including:

a delivery capsule, disposed at a distal portion of the tool, the delivery capsule including a proximal capsule-portion dimensioned to house a first part of the implant, and a distal capsule-portion dimensioned to house a second part of the implant; and

an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion including one or more controllers and one or more locks, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers, and the controllers and the locks are mechanically cooperative such that:

    • in a first state of the tool:
      • a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated,
      • a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited,
      • a proximal movement of the proximal capsule-portion proximally with respect to the implant is inhibited, and
      • responsively to movement of the distal capsule-portion distally, the tool automatically unlocks a second state of the tool;
    • in the second state of the tool:
      • the proximal movement of the proximal capsule-portion is facilitated,
      • the second distal movement of the distal capsule-portion remains inhibited, and
      • responsively to movement of the proximal capsule-portion proximally, the tool automatically unlocks a third state of the tool; and
    • in the third state of the tool:
      • the second distal movement of the distal capsule-portion is facilitated.

In an application, the tool automatically unlocks the second state responsively to the distal capsule-portion having moved the first distance.

In an application:

the one or more locks include a first lock and a second lock,

the one or more controllers include a first controller and a second controller,

in the first state of the tool, actuation of the first controller causes the first distal movement of the distal capsule-portion,

the tool automatically unlocks the second state by automatically making the first lock unlockable,

in the second state of the tool, actuation of the second controller causes the proximal movement of the proximal capsule-portion, and

the tool automatically unlocks the third state by automatically making the second lock unlockable.

In an application, in the third state of the tool, further actuation of the first controller causes the second distal movement of the distal capsule-portion.

In an application, the one or more controllers further include a third controller, and, in the third state of the tool, actuation of the third controller causes the second distal movement of the distal capsule-portion.

In an application, the implant is for use at a native mitral valve of a subject, and:

the first part of the implant includes an upstream support portion, configured to be placed against an upstream surface of the native mitral valve,

the second part of the implant includes a downstream end of the implant, and a plurality of flanges (i) disposed longitudinally between the upstream support portion and the downstream end, and (ii) configured to engage leaflets of the native mitral valve; and

the implant is housed by the delivery capsule such that the first distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the plurality of flanges, but not the downstream end of the implant.

In an application, the implant is housed by the delivery capsule such that the second distal movement of the distal capsule-portion unhouses, from the distal capsule-portion, the downstream end of the implant.

In an application, the implant is housed by the delivery capsule such that the proximal movement of the proximal capsule-portion unhouses, from the proximal capsule-portion, the upstream support portion.

In an application, the implant includes:

a valve frame that includes:

    • a tubular portion shaped to define a lumen therethrough, and
    • the upstream support portion, extending from an upstream end of the tubular portion;

an outer frame that circumscribes the tubular portion, and includes the plurality of flanges; and

a plurality of prosthetic leaflets, coupled to the tubular portion within the lumen.

In an application, the second part of the implant includes at least part of the tubular portion.

There is further provided, in accordance with an application of the present invention, a method, including:

percutaneously advancing an implant to a native heart valve of a subject, the implant housed in a compressed state within a delivery tool;

unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant;

subsequently, unhousing the longitudinally-proximal portion of the implant; and

subsequently, unhousing the longitudinally-distal portion of the implant.

In an application:

unhousing the longitudinally-intermediate portion of the implant includes unhousing flanges of the implant such that the flanges automatically expand;

unhousing the longitudinally-proximal portion of the implant includes unhousing an upstream support portion of the implant such that the upstream support portion automatically expands; and

unhousing the longitudinally-distal portion of the implant includes unhousing the longitudinally-distal portion of the implant such that the longitudinally-distal portion of the implant automatically expands.

In an application, the longitudinally-distal portion includes a tubular portion within which a valve member is disposed, and unhousing the longitudinally-distal portion of the implant includes unhousing the longitudinally-distal portion of the implant such that the tubular portion expands to form a lumen and the valve member regulates one-way flow of blood through the lumen.

In an application, unhousing the longitudinally-distal portion of the implant includes facilitating expansion of the implant such that the tubular portion expands and the flanges become longitudinally closer to the upstream support portion.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including:

    • a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around the longitudinal axis; and
    • a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen; and

an outer frame:

    • coupled to the valve frame, and
    • including a ring that circumscribes the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage tissue of the ventricle,
      and:

each arm of the plurality of arms defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion, and the majority of the flexible portion is disposed further radially outward than the flange span.

In an application, the implant is configured such that the rigid portion provides resistance against axial movement of the implant, while the flexible portion facilitates conformation of the arm to anatomy of the atrium and/or lateral movement of the implant within the native valve.

In an application, each arm of the plurality of arms defines a serpentine shape in the flexible portion.

In an application, each arm of the plurality of arms defines a plurality of holes in the flexible portion.

In an application, less than 90 percent of the flexible portion is disposed further radially outward than the flange span.

In an application, more than 60 percent of the flexible portion is disposed further radially outward than the flange span.

In an application, for each arm of the plurality of arms, the flexible portion covers an overall surface area including (i) the area occupied by material from which the arm is formed, and (ii) spaces, and the material from which the arm is formed occupies less than 80 percent of the overall surface area.

In an application, the material from which the arm is formed occupies more than 20 percent of the overall surface area.

In an application, the material from which the arm is formed occupies less than 70 percent of the overall surface area.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

    • including a ring defined by a pattern of alternating peaks and troughs, the peaks being longitudinally closer to the upstream end than to the downstream end, and the troughs being longitudinally closer to the downstream end than to the upstream end, and the pattern of the ring having an amplitude longitudinally between the peaks and the troughs,
    • including a plurality of legs, each of the legs coupled to the ring at a respective trough, and
    • shaped to define a plurality of outer-frame coupling elements, each of the outer-frame coupling elements (i) coupled to the ring at a respective peak, and (ii) fixed with respect to a respective valve-frame coupling element,
      and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

the fixation of the outer-frame coupling elements to the valve-frame coupling elements is such that compression of the tubular portion from the expanded state toward the compressed state such that the valve-frame coupling elements pull the outer-frame coupling elements radially inward: (i) reduces a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements, and (ii) increases the amplitude of the pattern of the ring.

In an application, the ring circumscribes the tubular portion.

In an application, the valve-frame coupling elements are disposed circumferentially around the longitudinal axis between the upstream end and the downstream end but not at the upstream end nor at the downstream end.

In an application, the upstream support portion includes one or more fabric pockets disposed circumferentially, each pocket of the one or more pockets having an opening that faces a downstream direction.

In an application, the outer frame is coupled to the valve frame only via the fixation of the outer-frame coupling elements to the respective valve-frame coupling elements.

In an application, the apparatus further includes an upstream support portion that includes a plurality of arms that extend radially from the tubular portion, and:

the upstream support portion has (i) a constrained-arm state, and (ii) a released-arm state in which the arms extend radially outward from the tubular portion,

each leg has a tissue-engaging flange that has (i) a constrained-flange state, and (ii) a released-flange state in which the flange extends radially outward from the tubular portion, and

the apparatus has an intermediate state in which (i) the tubular portion is in its compressed state, (ii) the upstream support portion is in its released-arm state, and (iii) the legs are in their released-flange state.

In an application:

the apparatus includes an implant that includes the valve frame, the leaflets, and the outer frame, and

the apparatus further includes a tool:

    • including a delivery capsule dimensioned (i) to house and retain the implant in a compressed state of the implant in which (a) the tubular portion is in its compressed state, (b) the upstream support portion is in its constrained-arm state, and (c) the legs are in their constrained-flange state, and (ii) to be advanced percutaneously to the heart of the subject while the implant is housed and in its compressed state, and
    • operable from outside the subject to:
      • transition the implant from its compressed state into the intermediate state while retaining the tubular portion in its compressed state, and
      • subsequently, expand the tubular portion toward its expanded state.

In an application, the tool is operable from outside the subject to transition the implant from its compressed state into the intermediate state by (i) releasing the legs into their released-flange state, while retaining the tubular portion in its compressed state, and (ii) subsequently, releasing the upstream support portion into its released-arm state, while retaining the tubular portion in its compressed state.

In an application, the tool is operable from outside the subject to transition the implant from its compressed state into the intermediate state by (i) releasing the upstream support portion into its released-arm state, while retaining the tubular portion in its compressed state, and (ii) subsequently, releasing the legs into their released-flange state, while retaining the tubular portion in its compressed state.

In an application, the fixation of the outer-frame coupling elements to the valve-frame coupling elements is such that, when the apparatus is in its intermediate state, expansion of the tubular portion from its compressed state toward its expanded state moves the flanges longitudinally away from the valve-frame coupling elements.

In an application, the fixation of the outer-frame coupling elements to the valve-frame coupling elements is such that, when the apparatus is in its intermediate state, expansion of the tubular portion from its compressed state toward its expanded state reduces the amplitude of the pattern of the ring and passes the flanges between the arms.

In an application, the upstream support portion further includes a covering that covers the arms to form an annular shape in the released-arm state, and, when the apparatus is in its intermediate state, expansion of the tubular portion from its compressed state toward its expanded state presses the flanges onto the covering.

In an application, in the compressed state of the tubular portion, a downstream end of each leg is longitudinally closer than the valve-frame coupling elements to the downstream end, and the flange of each leg is disposed longitudinally closer than the valve-frame coupling elements to the upstream end.

In an application, in the expanded state of the tubular portion, the downstream end of each leg is longitudinally closer than the valve-frame coupling elements to the downstream end, and the flange of each leg is disposed longitudinally closer than the valve-frame coupling elements to the upstream end.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve of a heart of a subject, the apparatus including an implant that includes:

a valve frame that includes a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the tubular portion having an upstream end, a downstream end, a longitudinal length therebetween, and a diameter transverse to the longitudinal axis;

a valve member, coupled to the tubular portion, disposed within the lumen, and arranged to provide unidirectional upstream-to-downstream flow of blood through the lumen;

an upstream support portion, coupled to the tubular portion; and

an outer frame, coupled to the tubular portion, and including a tissue-engaging flange,

and:

the implant has a first state and a second state,

in both the first state and the second state, (i) the upstream support portion extends radially outward from the tubular portion, and (ii) the tissue-engaging flange extends radially outward from the tubular portion, and

the tubular portion, the upstream support portion, and the outer frame are arranged such that transitioning of the implant from the first state toward the second state:

    • increases the diameter of the tubular portion by a diameter-increase amount,
    • decreases the length of the tubular portion by a length-decrease amount, and
    • moves the flange a longitudinal distance toward or toward-and-beyond the upstream support portion, the distance being greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is more than 20 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is more than 30 percent greater than the length-decrease amount.

In an application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is more than 40 percent greater than the length-decrease amount.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

    • a ring defined by a pattern of alternating peaks and troughs:
      • the peaks being longitudinally closer than the troughs to the upstream end,
      • the peaks being fixed to respective sites of the tubular portion at respective coupling points disposed circumferentially around the longitudinal axis, and
      • the pattern of the ring having an amplitude longitudinally between the peaks and the troughs; and
    • a plurality of legs, each of the legs coupled to the ring at a respective trough,
      and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

the fixation of the peaks to the respective sites of the tubular portion is such that compression of the tubular portion from the expanded state toward the compressed state such that the respective sites of the tubular portion pull the peaks radially inward via radially-inward tension on the coupling points: (i) reduces a circumferential distance between each of the coupling points and its adjacent coupling points, and (ii) increases the amplitude of the pattern of the ring.

In an application, the outer frame is coupled to the valve frame only via the fixation of the peaks to the respective sites of the tubular portion at the respective coupling points.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the valve frame defining a plurality of valve-frame coupling elements disposed circumferentially around the longitudinal axis;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen;

an outer frame:

    • including a ring defined by a pattern of alternating peaks and troughs, the peaks being longitudinally closer to the upstream end than to the downstream end, and the troughs being longitudinally closer to the downstream end than to the upstream end, and the pattern of the ring having an amplitude longitudinally between the peaks and the troughs,
    • including a plurality of legs, each of the legs coupled to the ring at a respective trough, and
    • shaped to define a plurality of outer-frame coupling elements, each of the outer-frame coupling elements (i) coupled to the ring at a respective peak, and (ii) fixed with respect to a respective valve-frame coupling element,
      and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

the fixation of the outer-frame coupling elements with respect to the valve-frame coupling elements is such that compression of the tubular portion from the expanded state toward the compressed state (i) pulls the outer-frame coupling elements radially inward via radially-inward pulling of the valve-frame coupling elements on the outer-frame coupling elements, (ii) reduces a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements, and (iii) increases the amplitude of the pattern of the ring, without increasing a radial gap between the valve frame and the ring by more than 1.5 mm.

In an application, the outer frame is coupled to the valve frame only via the fixation of the outer-frame coupling elements to the respective valve-frame coupling elements.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen;

an outer frame, including:

    • a ring defined by a pattern of alternating peaks and troughs:
      • the peaks being longitudinally closer than the troughs to the upstream end,
      • the peaks being fixed to respective sites of the tubular portion at respective coupling points disposed circumferentially around the longitudinal axis, and
      • the pattern of the ring having an amplitude longitudinally between the peaks and the troughs; and
    • a plurality of legs, each of the legs coupled to the ring at a respective trough,
      and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

the fixation of the peaks to the respective sites of the tubular portion is such that compression of the tubular portion from the expanded state toward the compressed state (i) pulls the peaks radially inward via radially-inward pulling of the respective sites of the tubular portion on the peaks, (ii) reduces a circumferential distance between each of the coupling points and its adjacent coupling points, and (iii) increases the amplitude of the pattern of the ring, without increasing a radial gap between the valve frame and the ring by more than 1.5 mm.

In an application, the outer frame is coupled to the valve frame only via the fixation of the peaks to the respective sites of the tubular portion at the respective coupling points.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the tubular portion having an upstream end, a downstream end, and defining a plurality of valve-frame coupling elements disposed circumferentially around the longitudinal axis between the upstream end and the downstream end but not at the upstream end nor at the downstream end;

a plurality of prosthetic leaflets, disposed within the lumen, and arranged to provide unidirectional flow of blood through the lumen;

an outer frame:

    • including a ring defined by a pattern of alternating peaks and troughs, the peaks being longitudinally closer to the upstream end than to the downstream end, and the troughs being longitudinally closer to the downstream end than to the upstream end,
    • including a plurality of legs, each of the legs coupled to the ring at a respective trough, and
    • shaped to define a plurality of outer-frame coupling elements, each of the outer-frame coupling elements (i) coupled to the ring at a respective peak, and (ii) fixed with respect to a respective valve-frame coupling element at a respective coupling point,
      and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

expansion of the tubular portion from the compressed state toward the expanded state (i) increases a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements, and (ii) moves the plurality of legs in a longitudinally upstream direction with respect to the tubular portion.

In an application, the outer frame is coupled to the valve frame only via the fixation of the outer-frame coupling elements to the respective valve-frame coupling elements.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a valve frame, including a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, the tubular portion having an upstream end and a downstream end;

a plurality of prosthetic leaflets, disposed within the lumen, and arranged to provide unidirectional flow of blood through the lumen;

an outer frame, including:

    • a ring defined by a pattern of alternating peaks and troughs:
      • the peaks being longitudinally closer than the troughs to the upstream end,
      • the peaks being fixed to respective sites of the tubular portion at respective coupling points disposed circumferentially around the longitudinal axis between the upstream end and the downstream end but not at the upstream end nor the downstream end; and
      • a plurality of legs, each of the legs coupled to the ring at a respective trough,
        and:

the tubular portion has (i) a compressed state in which the tubular portion has a compressed diameter, and (ii) an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

expansion of the tubular portion from the compressed state toward the expanded state (i) increases a circumferential distance between each of the coupling points and its adjacent coupling points, and (ii) moves the plurality of legs in a longitudinally upstream direction with respect to the tubular portion.

In an application, the outer frame is coupled to the valve frame only via the fixation of the peaks to the respective sites of the tubular portion at the respective coupling points.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve of a heart of a subject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and a central longitudinal axis therebetween, and including:

    • a valve frame, including:
      • a tubular portion having an upstream end and a downstream end, and shaped to define a lumen therebetween, and
      • an upstream support portion, extending from the upstream end of the tubular portion; and
    • at least one leg, coupled to the valve frame at a coupling point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitate one-way liquid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in which the tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

is configured such that increasing the diameter of the tubular portion toward the expanded diameter causes longitudinal movement:

    • of the upstream support portion toward the coupling point, and
    • of the tissue-engaging flange away from the coupling point.

In an application:

the apparatus includes an implant that includes the frame assembly and the valve member, and

the apparatus further includes a tool:

    • including a delivery capsule dimensioned (i) to house and retain the implant in the compressed state, and (ii) to be advanced percutaneously to the heart of the subject while the implant is housed and in the compressed state, and
    • operable from outside the subject to facilitate an increase of the diameter of the tubular portion from the compressed diameter toward the expanded diameter such that the increase of the diameter actuates longitudinal movement:
      • of the upstream support portion toward the coupling point, and
      • of the tissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes longitudinal movement of the upstream end of the tubular portion toward the coupling point.

In an application, the coupling point is disposed closer to the downstream end of the frame assembly than are either the tissue-engaging flange or the upstream support portion.

In an application, in the expanded state of the frame assembly, the leg extends away from the central longitudinal axis.

In an application:

the expanded state of the frame assembly is a fully-expanded state of the frame assembly,

the leg is expandable into an expanded state of the leg, independently of increasing the diameter of the tubular portion, and

in the expanded state of the leg, the leg extends away from the central longitudinal axis.

In an application:

in the expanded state of the frame assembly, the leg extends away from the central longitudinal axis, and

in the compressed state of the frame assembly, the leg is generally parallel with the central longitudinal axis.

In an application, the frame assembly is configured such that the longitudinal movement of the tissue-engaging flange away from the coupling point is a translational movement of the tissue-engaging flange that does not include rotation of the tissue-engaging flange.

In an application, the frame assembly is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes 1-20 mm of longitudinal movement of the tissue-engaging flange away from the coupling point.

In an application, the frame assembly is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes 1-20 mm of longitudinal movement of the upstream support portion toward the coupling point.

In an application, the frame assembly is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state reduces a distance between the upstream support portion and the tissue-engaging flange by 5-30 mm.

In an application, the frame assembly is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state moves the tissue-engaging flange longitudinally past the upstream support portion.

In an application:

the tubular portion is defined by a plurality of cells of the valve frame, and

increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state:

    • includes (i) increasing a width, orthogonal to the longitudinal axis of the frame assembly, of each cell, and (ii) reducing a height, parallel with the longitudinal axis of the frame assembly, of each cell, and
    • causes longitudinal movement of the upstream support portion toward the coupling point by reducing a height, parallel with the longitudinal axis of the frame assembly, of the tubular portion, by reducing the height of each cell.

In an application, the leg is disposed on an outside of the tubular portion.

In an application:

the at least one leg includes a plurality of legs,

the coupling point includes a plurality of coupling points, and

the frame assembly includes a leg frame that circumscribes the tubular portion, includes the plurality of legs, and is coupled to the valve frame at the plurality of coupling points, such that the plurality of legs is distributed circumferentially around the tubular portion.

In an application, the plurality of coupling points is disposed circumferentially around the frame assembly on a transverse plane that is orthogonal to the longitudinal axis of the frame assembly.

In an application, the plurality of legs is coupled to the valve frame via a plurality of struts, each strut:

having a first end that is coupled to a leg of the plurality of legs, and a second end that is coupled to a coupling point of the plurality of coupling points,

in the compressed state of the frame assembly, being disposed at a first angle in which the first end is disposed closer to the downstream end of the frame assembly than is the second end, and

being deflectable with respect to the coupling point of the plurality of coupling points, such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes the strut to deflect to a second angle in which the first end is disposed further from the downstream end of the frame assembly than is the first end in the compressed state of the frame assembly.

In an application, the leg frame is structured such that each leg of the plurality of legs is coupled to two struts of the plurality of struts, and two struts of the plurality of struts are coupled to each coupling point of the plurality of coupling points.

In an application, the leg is coupled to the valve frame via a strut, the strut:

having a first end that is coupled to the leg, and a second end that is coupled to the coupling point,

in the compressed state of the frame assembly, being disposed at a first angle in which the first end is disposed closer to the downstream end of the frame assembly than is the second end, and

being deflectable with respect to the coupling point, such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes the strut to deflect to a second angle in which the first end is disposed further from the downstream end of the frame assembly than is the first end in the compressed state of the frame assembly.

In an application, the at least one leg includes at least a first leg and a second leg.

In an application, the first leg and the second leg are both coupled to the valve frame at the coupling point.

In an application, the first leg is coupled to the coupling point via a respective first strut, and the second leg is coupled to the coupling point via a respective second strut.

In an application, the first and second legs, the first and second struts, and the coupling point are arranged such that, in the expanded state of the frame assembly:

the coupling point is disposed, circumferentially with respect to the tubular portion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to the tubular portion, between the coupling point and the first leg, and

the second strut is disposed, circumferentially with respect to the tubular portion, between the coupling point and the second leg.

In an application, the coupling point includes at least a first coupling point and a second coupling point.

In an application, the leg is coupled to the valve frame at the first coupling point and at the second coupling point.

In an application, the leg is coupled to the first coupling point via a respective first strut, and to the second coupling point via a respective second strut.

In an application, the first and second legs, the first and second struts, and the coupling point are arranged such that, in the expanded state of the frame assembly:

the leg is disposed, circumferentially with respect to the tubular portion, between the first strut and the second strut,

the first strut is disposed, circumferentially with respect to the tubular portion, between the leg and the first coupling point, and

the second strut is disposed, circumferentially with respect to the tubular portion, between the leg and the second coupling point.

In an application, in the expanded state of the frame assembly, the upstream support portion extends radially outward from the tubular portion.

In an application:

the expanded state of the frame assembly is a fully-expanded state of the frame assembly,

the upstream support portion is expandable into an expanded state of the upstream support portion, independently of increasing the diameter of the tubular portion, and

in the expanded state of the upstream support portion, the upstream support portion extends radially outward from the tubular portion.

In an application, in the compressed state of the frame assembly, the upstream support portion is generally tubular, collinear with the tubular portion, and disposed around the central longitudinal axis.

In an application, in the expanded state of the frame assembly, an inner region of the upstream support portion extends radially outward from the tubular portion at a first angle with respect to the tubular portion, and an outer region of the upstream support portion extends, from the inner region of the upstream support portion, further radially outward from the tubular portion at a second angle with respect to the tubular portion, the second angle being smaller than the first angle.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve of a heart of a subject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and a central longitudinal axis therebetween, and including:

    • a valve frame, including:
      • a tubular portion having an upstream end and a downstream end, and shaped to define a lumen therebetween, and
      • an upstream support portion, extending from the upstream end of the tubular portion; and
    • at least one leg, coupled to the valve frame at a coupling point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitate one-way liquid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart, in which the tubular portion has a compressed diameter,

is biased to assume an expanded state in which the tubular portion has an expanded diameter that is greater than the compressed diameter, and

is configured such that reducing the diameter of the tubular portion toward the compressed diameter causes longitudinal movement:

    • of the upstream support portion away from the coupling point, and
    • of the tissue-engaging flange toward the coupling point.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve of a heart of a subject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and a central longitudinal axis therebetween, including:

    • a valve frame, including:
      • a tubular portion having an upstream end and a downstream end, and shaped to define a lumen therebetween, and
      • an upstream support portion, extending from the upstream end of the tubular portion; and
    • at least one leg, coupled to the valve frame at a coupling point, and having a tissue-engaging flange; and

a valve member disposed within the lumen, and configured to facilitate one-way liquid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

and the frame assembly:

has a compressed state, for percutaneous delivery to the heart,

is intracorporeally expandable into an expanded state in which a diameter of the tubular portion is greater than in the compressed state, and

is configured such that increasing the diameter of the tubular portion by expanding the frame assembly toward the expanded state causes longitudinal movement of the tissue-engaging flange away from the coupling point.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve of a heart of a subject, the apparatus including:

a frame assembly, having an upstream end and a downstream end, and a central longitudinal axis therebetween, and including:

    • an inner frame including an inner-frame tubular portion that circumscribes the central longitudinal axis, has an upstream end and a downstream end, and defines a channel therebetween, the inner frame defining a plurality of inner-frame couplings disposed circumferentially at a longitudinal location of the inner frame,
    • an outer frame including an outer-frame tubular portion that coaxially circumscribes at least a portion of the inner-frame tubular portion, the outer frame defining a plurality of outer-frame couplings disposed circumferentially at a longitudinal location of the outer frame, and
    • a plurality of connectors, each connector connecting a respective inner-frame coupling to a respective outer-frame coupling;

a liner, disposed over at least part of the inner-frame tubular portion; and

a plurality of prosthetic leaflets, coupled to the inner-frame tubular portion and disposed within the channel,

and:

the frame assembly: (i) is compressible by a radially-compressive force into a compressed state in which the inner frame is in a compressed state thereof and the outer frame is in a compressed state thereof, (ii) is configured, upon removal of the radially-compressive force, to automatically expand into an expanded state thereof in which the inner frame is in an expanded state thereof and the outer frame is in an expanded state thereof,

in the expanded state of the frame assembly, the prosthetic leaflets are configured to facilitate one-way fluid flow, in a downstream direction, through the channel, and

the connection of the inner-frame couplings to the respective outer-frame couplings is such that expansion of the frame assembly from the compressed state to the expanded state causes the inner-frame tubular portion to slide longitudinally in a downstream direction with respect to the outer-frame tubular portion.

There is further provided, in accordance with an application of the present invention, apparatus for use with a native valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus including:

a tubular portion, having an upstream portion that includes an upstream end, and a downstream portion that includes a downstream end, and shaped to define a lumen between the upstream portion and the downstream portion;

a plurality of prosthetic leaflets, disposed within the lumen, and arranged to provide unidirectional flow of blood from the upstream portion to the downstream portion;

an annular upstream support portion:

    • having an inner portion that extends radially outward from the upstream portion, and
    • including one or more fabric pockets disposed circumferentially around the inner portion, each pocket of the one or more pockets having an opening that faces a downstream direction.

In an application:

the upstream support portion includes (i) a plurality of arms that extend radially outward from the tubular portion, and (ii) a covering, disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of the upstream support portion, and (ii) a radially-outer part at the outer portion of the upstream support portion,

at the inner portion of the upstream support portion, the covering is closely-fitted between the radially-inner parts of the arms, and

at the outer portion of the upstream support portion, the pockets are formed by the covering being loosely-fitted between the radially-outer parts of the arms.

In an application:

the upstream support portion includes (i) a plurality of arms that extend radially outward from the tubular portion, and (ii) a covering, disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of the upstream support portion, and (ii) a radially-outer part at the outer portion of the upstream support portion, the radially-outer part being more flexible than the radially-inner part.

In an application:

the upstream support portion includes (i) a plurality of arms that extend radially outward from the tubular portion, and (ii) a covering, disposed over the plurality of arms,

each arm has (i) a radially-inner part at the inner portion of the upstream support portion, and (ii) a radially-outer part at the outer portion of the upstream support portion,

at the outer portion of the upstream support portion, the pockets are formed by each arm curving to form a hook shape.

In an application, each pocket is shaped and arranged to billow in response to perivalvular flow of blood in an upstream direction.

In an application, the apparatus is configured to be transluminally delivered to the heart, and implanted at the native valve by expansion of the apparatus, such that the upstream support portion is disposed in the atrium and the tubular portion extends from the upstream support portion into the ventricle, and each pocket is shaped and arranged such that perivalvular flow of blood in an upstream direction presses the pocket against tissue of the atrium.

There is further provided, in accordance with an application of the present invention, apparatus including:

a plurality of prosthetic valve leaflets; and

a frame assembly, including:

    • a tubular portion defined by a repeating pattern of cells, the tubular portion extending circumferentially around a longitudinal axis so as to define a longitudinal lumen, the prosthetic valve leaflets coupled to the inner frame and disposed within the lumen;
    • an outer frame, including a plurality of legs, distributed circumferentially around the tubular portion, each leg having a tissue-engaging flange;
    • an upstream support portion that includes a plurality of arms that extend radially outward from the tubular portion; and
    • a plurality of appendages, each having a first end that defines a coupling element via which the tubular portion is coupled to the outer frame, and a second end;
      and the frame assembly defines a plurality of hubs, distributed circumferentially around the longitudinal axis on a plane that is transverse to the longitudinal axis, each hub defined by convergence and connection of, (i) two adjacent cells of the tubular portion, (ii) an arm of the plurality of arms, and (iii) an appendage of the plurality of appendages.

In an application, each hub has six radiating spokes, two of the six spokes being part of a first cell of the two adjacent cells, two of the six spokes being part of a second cell of the two adjacent cells, one of the six spokes being the arm, and one of the six spokes being the second end of the appendage.

In an application, the appendages are in-plane with the tubular portion.

In an application, the appendages are in-plane with the outer frame.

There is further provided, in accordance with an application of the present invention, a method for use with a native valve of a heart of a subject, the method including:

percutaneously advancing to heart, an implant:

    • including a valve frame, a valve member disposed within a lumen defined by the valve frame, and at least one leg, coupled to the valve frame at a coupling point, and
    • having an upstream end, a downstream end, and a central longitudinal axis therebetween;

positioning the implant within the heart such that a tissue-engaging flange of the leg is disposed downstream of the valve, and thereafter causing the flange to protrude radially outward from the axis;

subsequently, while an upstream support portion of the valve frame is disposed upstream of the valve, causing the upstream support portion to protrude radially outward from the axis, such that tissue of the valve is disposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream support portion and the flange by reducing a distance between the upstream support portion and the flange by causing longitudinal movement (i) of the upstream support portion toward the coupling point, and (ii) of the tissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstream support portion toward the coupling point, and (ii) of the tissue-engaging flange away from the coupling point, includes causing the longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of the present invention, a method for use with a native valve of a heart of a subject, the method including:

percutaneously advancing to heart, an implant:

    • including a valve frame, a valve member disposed within a lumen defined by the valve frame, and at least one leg, coupled to the valve frame at a coupling point, and
    • having an upstream end, a downstream end, and a central longitudinal axis therebetween;

positioning the implant within the heart such that an upstream support portion of the valve frame is disposed upstream of the valve, and thereafter causing the upstream support portion to protrude radially outward from the axis;

subsequently, while a tissue-engaging flange of the leg is disposed downstream of the valve, causing the tissue-engaging flange to protrude radially outward from the axis, such that tissue of the valve is disposed between the upstream support portion and the flange; and

subsequently, sandwiching the tissue between the upstream support portion and the flange by reducing a distance between the upstream support portion and the flange by causing longitudinal movement (i) of the upstream support portion toward the coupling point, and (ii) of the tissue-engaging flange away from the coupling point.

In an application, causing the longitudinal movement (i) of the upstream support portion toward the coupling point, and (ii) of the tissue-engaging flange away from the coupling point, includes causing the longitudinal movement by increasing a diameter of the lumen.

There is further provided, in accordance with an application of the present invention, a method for use with a native valve of a heart of a subject, the method including:

percutaneously advancing an implant to the heart, the implant:

    • having an upstream end, a downstream end, and a central longitudinal axis therebetween, and
    • including a tubular portion, an upstream support portion, and a plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream support portion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engaging flanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

    • causing the upstream support portion to extend radially outward from the axis so as to have a first support-portion span, and
    • causing the flanges to extend radially outward from the axis so as to have a first flange span; and

subsequently, causing the upstream support portion and the flanges move toward each other by at least 5 mm by increasing a diameter of the tubular portion such that:

    • the upstream support portion extends radially outward so as to have a second support-portion span, the first support-portion span being at least 40 percent as great as the second support-portion span, and
    • the flanges extend radially outward so as to have a second flange span, the first flange span being at least 30 percent as great as the second flange span.

There is further provided, in accordance with an application of the present invention, a method for use with a native valve of a heart of a subject, the method including:

percutaneously advancing an implant to the heart, the implant:

    • having an upstream end, a downstream end, and a central longitudinal axis therebetween, and
    • including a tubular portion, an upstream support portion, and a plurality of tissue-engaging flanges;

positioning the implant within the heart such that the upstream support portion is disposed upstream of the valve,

positioning the implant within the heart such that the tissue-engaging flanges are disposed downstream of the valve,

without increasing a diameter of the tubular portion:

    • causing the upstream support portion to extend radially outward from the axis, and
    • causing the flanges to extend radially outward from the axis so as to have a first flange span; and

subsequently, by increasing a diameter of the tubular portion:

    • causing the upstream support portion and the flanges move toward each other by at least 5 mm,
    • causing the upstream support portion to move further radially outward from the axis, and
    • causing each flange of the plurality of flanges to translate radially outward so as to have a second flange span that is greater than the first flange span.

The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-H are schematic illustrations of an implant for use with a native valve of a heart of a subject, in accordance with some applications of the invention;

FIGS. 3A-C are schematic illustrations that show structural changes in a frame assembly during transitioning of the assembly between its compressed and expanded states, in accordance with some applications of the invention;

FIGS. 4A-F are schematic illustrations of implantation of the implant at the native valve, in accordance with some applications of the invention;

FIG. 5 is a schematic illustration of a step in the implantation of the implant, in accordance with some applications of the invention;

FIG. 6 is a schematic illustration of the implant, in accordance with some applications of the invention;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies of respective implants, in accordance with some applications of the invention; and

FIGS. 9A-C are schematic illustrations of an implant comprising a frame assembly, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-H, which are schematic illustrations of an implant 20 for use with a native valve of a heart of a subject, in accordance with some applications of the invention. Implant 20 comprises a frame assembly 22 that has an upstream end 24, a downstream end 26, and a central longitudinal axis ax1 therebetween. Frame assembly 22 comprises a valve frame 30 that comprises a tubular portion 32 that has an upstream end 34 and a downstream end 36, and is shaped to define a lumen 38 through the tubular portion from the upstream end to the downstream end. Tubular portion 32 circumscribes axis ax1, and thereby defines lumen 38 along the axis. Valve frame 30 further comprises an upstream support portion 40, extending from upstream end 34 of tubular portion 32. Frame assembly 22 further comprises at least one leg 50, coupled to valve frame 30 at (e.g., via) a coupling point 52, and having a tissue-engaging flange 54.

Typically, and as described hereinbelow, leg 50 is part of an outer frame (or “leg frame”) 60, and frames 30 and 60 define respective coupling elements 31 and 61, which are fixed with respect to each other at coupling points 52. Typically, frames 30 and 60 are coupled to each other only at coupling points 52 (e.g., only via the fixation of coupling elements 31 and 61 with respect to each other).

Implant 20 further comprises a valve member 58 (e.g., one or more prosthetic leaflets) disposed within lumen 38, and configured to facilitate one-way liquid flow through the lumen from upstream end 34 to downstream end 36 (e.g., thereby defining the orientation of the upstream and downstream ends of tubular portion 32). FIG. 1A shows implant 20 in a fully-expanded state, in which frame assembly 22 is in a fully-expanded state. FIG. 1B shows an exploded view of frame assembly 22 in its fully-expanded state. FIGS. 2A-E show respective states of implant 20, which will be discussed in more detail hereinbelow with respect to the implantation of the implant and the anatomy in which the implant is implanted. FIG. 2A shows implant 20 in a compressed state (in which frame assembly 22 is in a compressed state), for percutaneous delivery of the implant to the heart of the subject. Typically, in the compressed state, leg 50 (including flange 54 thereof) is in a constrained-flange state in which the flange is generally parallel with axis ax1. Further typically, in the compressed state, upstream support portion 40 is generally tubular, collinear with tubular portion 32 (e.g., extending collinearly from the tubular portion), and disposed around axis ax1.

FIG. 2B shows a state of implant 20 in which tissue-engaging flange 54 of each leg 50 extends radially away from axis ax1 (e.g., radially away from tubular portion 32). FIG. 2C shows a state of implant 20 in which upstream-support portion 40 extends radially away from axis ax1 (and thereby radially away from tubular portion 32). FIG. 2D shows a state of implant 20 in which both flange 54 and portion 40 extend away from axis ax1. In the fully-expanded state (FIGS. 1A-B) both upstream support portion 40 and flange 54 extend radially away from axis ax1. Typically, frame assembly 22 is biased (e.g., shape-set) to assume its fully-expanded state, which is shown in FIG. 2E. Transitioning of implant 20 between the respective states is typically controlled by delivery apparatus, such as by constraining the implant in a compressed state within a delivery tube and/or against a control rod, and selectively releasing portions of the implant to allow them to expand.

In the compressed state of frame assembly 22, tubular portion 32 has a diameter d1, and in the expanded state, the tubular portion has a diameter d2 that is greater that diameter d1. For some applications, diameter d1 is 4-15 mm, (e.g., 5-11 mm) and diameter d2 is 20-50 mm, (e.g., 23-33 mm). Frame assembly 22 is configured such that increasing the diameter of tubular portion 32 (e.g., from d1 to d2) causes longitudinal movement of flange 54 away from coupling point 52. In the same way, reducing the diameter of tubular portion 32 (e.g., from d2 to d1) causes longitudinal movement of flange 54 toward coupling point 52. It is to be noted that the term “longitudinal movement” (including the specification and the claims) means movement parallel with central longitudinal axis ax1. Therefore, longitudinal movement of flange 54 away from coupling point 52 means increasing a distance, measured parallel with longitudinal axis ax1, between flange 54 and coupling point 52. An example of such a configuration is described in more detail with respect to FIG. 3A.

Thus, expansion of tubular portion 32 from its compressed state toward its expanded state (i) increases a circumferential distance between each of coupling points 52 and its adjacent coupling points (e.g., between each of outer-frame coupling elements 61 and its adjacent outer-frame coupling elements) (e.g., from d8 to d9), and (ii) moves legs 50 in a longitudinally upstream direction with respect to the tubular portion.

Typically, frame assembly 22 is configured such that increasing the diameter of tubular portion 32 also causes longitudinal movement of upstream support portion 40 toward coupling point 52, e.g., as described in more detail with respect to FIGS. 3B-C. Typically, frame assembly 22 is configured such that increasing the diameter of tubular portion 32 also causes longitudinal movement of upstream end 34 of tubular portion 32 toward coupling point 52. In the same way, reducing the diameter of tubular portion 32 causes longitudinal movement of upstream end 34 away from coupling point 52.

For some applications, upstream support portion 40 comprises a plurality of arms 46 that each extends radially outward from tubular portion 32 (e.g., from upstream end 34 of the tubular portion). Arms 46 are typically flexible. For some such applications, arms 46 are coupled to tubular portion 32 such that each arm may deflect independently of adjacent arms during implantation (e.g., due to anatomical topography).

For some applications, upstream support portion 40 comprises a plurality of barbs 48 that extend out of a downstream surface of the upstream support portion. For example, each arm 46 may comprise one or more of barbs 48. Barbs 48 press into tissue upstream of the native valve (e.g., into the valve annulus), thereby inhibiting downstream movement of implant 20 (in addition to inhibition of downstream movement provided by the geometry of upstream support portion 40).

One or more surfaces of frame assembly 22 are covered with a covering 23, which typically comprises a flexible sheet, such as a fabric, e.g., comprising polyester. Typically, covering 23 covers at least part of tubular portion 32, typically lining an inner surface of the tubular portion, and thereby defining lumen 38.

Further typically, upstream support portion 40 is covered with covering 23, e.g., extending between arms 46 to form an annular shape. It is hypothesized that this reduces a likelihood of paravalvular leakage. For such applications, excess covering 23 may be provided between arms 46 of upstream support portion 40, so as to facilitate their independent movement. Although FIG. 1A shows covering 23 covering an upstream side of upstream support portion 40, the covering typically additionally (or alternatively) covers the downstream side of the upstream support portion. For example, covering 23 may extend over the tips of arms 46 and down the outside of the arms, or a separate piece of covering may be provided on the downstream side of the upstream support portion.

Alternatively, each arm 46 may be individually covered in a sleeve of covering 23, thereby facilitating independent movement of the arms.

For some applications, at least part of legs 50 (e.g., flanges thereof) is covered with covering 23.

Typically, frame assembly 22 comprises a plurality of legs 50 (e.g., two or more legs, e.g., 2-16 legs, such as 4-12 legs, such as 6-12 legs), arranged circumferentially around valve frame 30 (e.g., around the outside of tubular portion 32). Typically, frame assembly 22 comprises a plurality of coupling points 52 at which the legs are coupled to valve frame 30.

As described in more detail hereinbelow (e.g., with reference to FIG. 3A), each leg 50 is typically coupled to a coupling point 52 via a strut 70. For some applications, each leg 50 is coupled to a plurality of (e.g., two) coupling points 52 via a respective plurality of (e.g., two) struts 70. For some such applications, frame assembly 22 is arranged such that, in the expanded state of the frame assembly, leg 50 is disposed, circumferentially with respect to tubular portion 32, between two struts, and each of the two struts are disposed, circumferentially with respect to the tubular portion, between the leg and a respective coupling point 52.

For some applications, a plurality of (e.g., two) legs are coupled to each coupling point 52 via a respective plurality of (e.g., two) struts 70. For some such applications, frame assembly 22 is arranged such that, in the expanded state of the frame assembly, coupling point 52 is disposed, circumferentially with respect to tubular portion 32, between two struts 70, and each of the two struts are disposed, circumferentially with respect to the tubular portion, between the coupling point and a respective leg 50.

For some applications, frame assembly 22 comprises an outer frame (e.g., a leg frame) 60 that circumscribes tubular portion 32, comprises (or defines) the plurality of legs 50 and the plurality of struts 70, and is coupled to valve frame 30 at the plurality of coupling points 52, such that the plurality of legs is distributed circumferentially around the tubular portion. For such applications, outer frame 60 comprises a ring 66 that is defined by a pattern of alternating peaks 64 and troughs 62, and that typically circumscribes tubular portion 32. For example, the ring may comprise struts 70, extending between the peaks and troughs. Peaks 64 are longitudinally closer to upstream end 34 of tubular portion 32 than to downstream end 36, and troughs 62 are longitudinally closer to the downstream end than to the upstream end. (It is to be noted that throughout this patent application, including the specification and the claims, the term “longitudinally” means with respect to longitudinal axis ax1. For example, “longitudinally closer” means closer along axis ax1 (whether positioned on axis ax1 or lateral to axis ax1), and “longitudinal movement” means a change in position along axis ax1 (which may be in additional to movement toward or away from axis ax1).) Therefore, peaks 64 are closer than troughs 62 to upstream end 34, and troughs 62 are closer than peaks 64 to downstream end 36. For applications in which frame 60 comprises ring 66, each leg 50 is coupled to the ring (or defined by frame 60) at a respective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66 having a generally zig-zag shape. However, the scope of the invention includes ring 66 having another shape that defines peaks and troughs, such as a serpentine or sinusoid shape.

For applications in which frame assembly 22 has a plurality of coupling points 52, the coupling points (and therefore coupling elements 31 and 61) are disposed circumferentially around the frame assembly (e.g., around axis ax1), typically on a transverse plane that is orthogonal to axis ax1. This transverse plane is illustrated by the position of section A-A in FIG. 2B. Alternatively, coupling points 52 may be disposed at different longitudinal heights of frame assembly 22, e.g., such that different flanges 54 are positioned and/or moved differently to others.

Typically, coupling points 52 (and therefore coupling elements 31 and 61) are disposed longitudinally between upstream end 24 and downstream end 26 of frame assembly 22, but not at either of these ends. Further typically, coupling points 52 are disposed longitudinally between upstream end 34 and downstream end 36 of tubular portion 32, but not at either of these ends. For example, the coupling points may be more than 3 mm (e.g., 4-10 mm) both from end 34 and from end 36. It is hypothesized that this advantageously positions the coupling points at a part of tubular portion 32 that is more rigid than end 34 or end 36.

It is to be noted that leg 50 is typically expandable into its expanded state (e.g., a released-flange state) such that flange 54 extends away from axis ax1, independently of increasing the diameter of tubular portion 32 (e.g., as shown in FIGS. 2B & 2D). Similarly, upstream support portion 40 is typically expandable into its expanded state (e.g., a released-arm state) such that it (e.g., arms 46 thereof) extends away from axis ax1, independently of increasing the diameter of tubular portion 32 (e.g., as shown in FIG. 2C & 2D). The state shown in FIG. 2D may be considered to be an intermediate state. Therefore, implant 20 is typically configured such that legs 50 (e.g., flanges 54 thereof) and upstream support portion 40 are expandable such that they both extend away from axis ax1, while retaining a distance d3 therebetween. This distance is subsequently reducible to a distance d4 by expanding tubular portion 32 (e.g., shown in FIG. 2E).

For some applications, while tubular portion 32 remains in its compressed state, flange 54 can extend away from axis ax1 over 40 percent (e.g., 40-80 percent, such as 40-70 percent) of the distance that it extends from the axis subsequent to the expansion of the tubular portion. For example, for applications in which implant 20 comprises a flange on opposing sides of the implant, a span d15 of the flanges while tubular portion 32 is in its compressed state may be at least 40 percent (e.g., 40-80 percent, such as 40-70 percent) as great as a span d16 of the flanges subsequent to the expansion of the tubular portion. For some applications, span d15 is greater than 15 mm and/or less than 50 mm (e.g., 20-30 mm). For some applications, span d16 is greater than 30 mm and/or less than 60 mm (e.g., 40-50 mm). It is to be noted that flange 54 is effectively fully expanded, with respect to other portions of leg 50 and/or with respect to tubular portion 32, before and after the expansion of the tubular portion.

Similarly, for some applications, while tubular portion 32 remains in its compressed state, upstream support portion 40 (e.g., arms 46) can extend away from axis ax1 over 30 percent (e.g., 30-70 percent) of the distance that it extends from the axis subsequent to the expansion of the tubular portion. That is, for some applications, a span d17 of the upstream support portion while tubular portion 32 is in its compressed state may be at least 30 percent (e.g., 30-70 percent) as great as a span d18 of the upstream support portion subsequent to the expansion of the tubular portion. For some applications, span d17 is greater than 16 mm (e.g., greater than 20 mm) and/or less than 50 mm (e.g., 30-40 mm). For some applications, span d18 is greater than 40 mm and/or less than 65 mm (e.g., 45-56 mm, such as 45-50 mm). It is to be noted that upstream support portion 40 is effectively fully expanded, with respect to tubular portion 32, before and after the expansion of the tubular portion.

It is to be noted that when tubular portion 32 is expanded, flanges 54 typically translate radially outward from span d15 to span d16 (e.g., without deflecting). Typically, upstream support portion 40 behaves similarly (e.g., arms 46 translated radially outward from span d17 to span d18, e.g., without deflecting). That is, an orientation of each flange 54 and/or each arm 46 with respect to tubular portion 32 and/or axis ax1 is typically the same in the state shown in FIG. 2D as it is in the state shown in FIG. 2E. Similarly, for some applications an orientation of each flange 54 with respect to upstream support portion 40 (e.g., with respect to one or more arms 46 thereof) is the same before and after expansion of tubular portion 32.

For some applications, increasing the diameter of tubular portion 32 from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement of flange 54 away from coupling point 52. For some applications, increasing the diameter of tubular portion 32 from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement of upstream support portion 40 toward coupling point 52. For some applications, distance d3 is 7-30 mm. For some applications, distance d4 is 0-15 mm (e.g., 2-15 mm). For some applications, increasing the diameter of tubular portion 32 from d1 to d2 reduces the distance between the upstream support portion and flanges 54 by more than 5 mm and/or less than 30 mm, such as 5-30 mm (e.g., 10-30 mm, such as 10-20 mm or 20-30 mm). For some applications, the difference between d3 and d4 is generally equal to the difference between d1 and d2. For some applications, the difference between d3 and d4 is more than 1.2 and/or less than 3 times (e.g., 1.5-2.5 times, such as about 2 times) greater than the difference between d1 and d2.

For some applications, flanges 54 curve such that a tip of each flange is disposed at a shallower angle with respect to inner region 42 of upstream support portion 40, than are portions of leg 50 that are closer to downstream end 26 of frame assembly 22. For some such applications, a tip of each flange may be generally parallel with inner region 42. For some such applications, while tubular portion 32 is in its expanded state, a tip portion 55 of each flange 54 that extends from the tip of the flange at least 2 mm along the flange, is disposed within 2 mm of upstream support portion 40. Thus, for some applications, while tubular portion 32 is in its expanded state, for at least 5 percent (e.g., 5-8 percent, or at least 8 percent) of span 18 of upstream support portion 40, the upstream support portion is disposed within 2 mm of a flange 54.

For some applications, in the absence of any obstruction (such as tissue of the valve or covering 23) between flange 54 and upstream support portion 40, increasing the diameter of tubular portion 32 from d1 to d2 causes the flange and the upstream support portion to move past each other (e.g., the flange may move between arms 46 of the upstream support portion), such that the flange is closer to the upstream end of implant 20 than is the upstream support portion, e.g., as shown hereinbelow for frame assemblies 122 and 222, mutatis mutandis. (For applications in which upstream support portion 40 is covered by covering 23, flanges 54 typically don't pass the covering. For example, in the absence of any obstruction, flanges 54 may pass between arms 46, and press directly against covering 23.) It is hypothesized that for some applications this configuration applies greater force to the valve tissue being sandwiched, and thereby further facilitates anchoring of the implant. That is, for some applications, distance d3 is smaller than the sum of distance d5 and a distance d14 (described with reference to FIG. 3C). For some applications, increasing the diameter of tubular portion 32 from d1 to d2 advantageously causes flanges 54 and upstream support portion 40 to move greater than 3 mm and/or less than 25 mm (e.g., greater than 5 mm and/or less than 15 mm, e.g., 5-10 mm, such as about 7 mm) with respect to each other (e.g., toward each other and then past each other).

For some applications, in the expanded state of frame assembly 22, upstream support portion 40 has an inner region (e.g., an inner ring) 42 that extends radially outward at a first angle with respect to axis ax1 (and typically with respect to tubular portion 32), and an outer region (e.g., an outer ring) 44 that extends, from the inner region, further radially outward from the tubular portion at a second angle with respect to the tubular portion, the second angle being smaller than the first angle. For example, for some applications inner region 42 extends radially outward at an angle alpha_1 of 60-120 degrees (e.g., 70-110 degrees) with respect to axis ax1, and outer region 44 extends radially outward at an angle alpha_2 of 5-70 degrees (e.g., 10-60 degrees) with respect to axis ax1.

It is to be noted that angles alpha_1 and alpha_2 are measured between the respective region support portion 40, and the portion of axis ax1 that extends in an upstream direction from the level of frame assembly 22 at which the respective region begins to extend radially outward.

For some applications in which implant 20 is configured to be placed at an atrioventricular valve (e.g., a mitral valve or a tricuspid valve) of the subject, region 42 is configured to be placed against the upstream surface of the annulus of the atrioventricular valve, and region 44 is configured to be placed against the walls of the atrium upstream of the valve.

For some applications, each arm 46 defines a rigid portion 43 and a flexible portion 45 that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. Typically, at least part of flexible portion 45 is disposed in outer region 44, and at least part of rigid portion 43 is disposed in inner region 42. Therefore, typically overall, outer region 44 is more flexible than inner region 42. To achieve this differential flexibility, each arm 46 may have a different structure in portion 45 and/or region 44, than it has in portion 43 and/or region 42.

FIG. 2G shows an arm 46a, which is a variant of arm 46. Arm 46a defines flexible portion 45a, which is a variant of flexible portion 45. In flexible portion 45a, the material from which arm 46a is formed is thinner than in rigid portion 43, but defines a serpentine or zig-zag pattern that increases the overall thickness of portion 45a, and as shown, may make the overall thickness of portion 45a equal to or greater than the overall thickness of portion 43.

FIG. 2H shows an arm 46b, which is a variant of arm 46. Arm 46b defines flexible portion 45b, which is a variant of flexible portion 45. In flexible portion 45b, arm 46b defines holes 47 in the material from which arm 46b is formed. Nonetheless, as shown, the overall thickness of portion 45b may be equal to or greater than the overall thickness of portion 43.

Therefore, as shown for arms 46a and 46b, flexible portion 45 covers an overall surface area including (i) the area in which the material from which the arm is formed occupies, and (ii) spaces, such as holes, or gaps between turns. For some applications, the material from which the arm is formed occupies less than 80 percent and/or more than 20 percent of the overall surface area (e.g., 20-80 percent, e.g., 40-80 percent, e.g., 40-70 percent of the overall surface area).

It is hypothesized that the relative rigidity of portion 43 and/or region 42 provides resistance against axial movement (e.g., ventricular migration) of implant 20, while the relative flexibility of portion 45 and/or region 44 facilitates conformation of upstream support portion 40 to the atrial anatomy and/or lateral movement of the implant within the native valve.

For some applications, and as shown (e.g., in FIGS. 1A and 2E-F), in the expanded state of frame assembly 22, the majority of flexible portion 45 (e.g., more than 60 percent and/or less than 90 percent) is disposed further radially outward than span d16 of flanges 54.

For some applications, two or more of arms 46 are connected by a connector (not shown), reducing the flexibility, and/or the independence of movement of the connected arms relative to each other. For some applications, arms 46 are connected in particular sectors of upstream support portion 40, thereby making these sectors more rigid than sectors in which the arms are not connected. For example, a relatively rigid sector may be provided to be placed against the posterior portion of the mitral annulus, and a relatively flexible sector may be provided to be placed against the anterior side of the mitral annulus, so as to reduce forces applied by upstream support portion 40 on the aortic sinus.

For some applications, and as shown, coupling points 52 are disposed closer to downstream end 26 of frame assembly 22 than are flanges 54, or is upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement of flange 54 away from coupling point 52 (and the typical movement of upstream support portion 40 toward the coupling point) facilitates the sandwiching of tissue of the native valve (e.g., leaflet and/or annulus tissue) between the flange and the upstream support portion, thereby securing implant 20 at the native valve.

Typically, in the compressed state of tubular portion 32, a downstream end of each leg 50 is longitudinally closer than valve-frame coupling elements 31 to downstream end 36, and flange 54 of each leg is disposed longitudinally closer than the valve-frame coupling elements to upstream end 34. Typically, this is also the case in the expanded state of tubular portion 32.

FIGS. 3A-C show structural changes in frame assembly 22 during transitioning of the assembly between its compressed and expanded states, in accordance with some applications of the invention. FIGS. 3A-C each show a portion of the frame assembly, the structural changes thereof being representative of the structural changes that occur in other portions of the frame assembly. FIG. 3A shows a leg 50 and struts 70 (e.g., a portion of outer frame 60), and illustrates the structural changes that occur around outer frame 60. FIG. 3B shows a portion of valve frame 30, and illustrates the structural changes that occur around the valve frame. FIG. 3C shows valve frame 30 as a whole. In each of FIGS. 3A-C, state (A) illustrates the structure while frame assembly 22 (and in particular tubular portion 32) is in its compressed state, and state (B) illustrates the structure while the frame assembly (and in particular tubular portion 32) is in its expanded state.

FIG. 3A shows structural changes in the coupling of legs 50 to coupling point 52 (e.g., structural changes of outer frame 60) during the transitioning of frame assembly 22 (and in particular tubular portion 32) between its compressed and expanded states. Each leg 50 is coupled to valve frame 30 via at least one strut 70, which connects the leg to coupling point 52. Typically, each leg 50 is coupled to valve frame 30 via a plurality of struts 70. A first end 72 of each strut 70 is coupled to leg 50, and a second end 74 of each strut is coupled to a coupling point 52. As described hereinabove, for applications in which frame 60 comprises ring 66, each leg 50 is coupled to the ring at a respective trough 62. Ring 66 may comprise struts 70, extending between the peaks and troughs, with each first end 72 at (or close to) a trough 62, and each second end 74 at (or close to) a peak 64.

In the compressed state of frame assembly 22 (and in particular of tubular portion 32), each strut 70 is disposed at a first angle in which first end 72 is disposed closer than second end 74 to the downstream end of the frame assembly. Expansion of frame assembly 22 (and in particular of tubular portion 32) toward its expanded state causes strut 70 to deflect to a second angle. This deflection moves first end 72 away from the downstream end of frame assembly 22. That is, in the expanded state of frame assembly 22, first end 72 is further from the downstream end of the frame assembly than it is when the frame assembly is in its compressed state. This movement is shown as a distance d5 between the position of end 72 in state (A) and its position in state (B). This movement causes the above-described movement of flanges 54 away from coupling points 52. As shown, flanges 54 typically move the same distance d5 in response to expansion of frame assembly 22.

For applications in which outer frame 60 comprises ring 66, the pattern of alternating peaks and troughs may be described as having an amplitude longitudinally between the peaks and troughs, i.e., measured parallel with central longitudinal axis ax1 of frame assembly 22, and the transition between the compressed and expanded states may be described as follows: In the compressed state of frame assembly 22 (and in particular of tubular portion 32), the pattern of ring 66 has an amplitude d20. In the expanded state frame assembly 22 (and in particular of tubular portion 32), the pattern of ring 66 has an amplitude d21 that is lower than amplitude d20. Because (i) it is at peaks 64 that ring 66 is coupled to valve frame 30 at coupling points 52, and (ii) it is at troughs 62 that ring 66 is coupled to legs 50, this reduction in the amplitude of the pattern of ring 66 moves legs 50 (e.g., flanges 54 thereof) longitudinally further from the downstream end of the frame assembly. The magnitude of this longitudinal movement (e.g., the difference between magnitudes d20 and d21) is equal to d5.

Typically, distance d5 is the same distance as the distance that flange 54 moves away from coupling point 52 during expansion of the frame assembly. That is, a distance between flange 54 and the portion of leg 50 that is coupled to strut 70, typically remains constant during expansion of the frame assembly. For some applications, the longitudinal movement of flange 54 away from coupling point 52 is a translational movement (e.g., a movement that does not include rotation or deflection of the flange).

For some applications, a distance d6, measured parallel to axis ax1 of frame assembly 22, between coupling point 52 and first end 72 of strut 70 while assembly 22 is in its compressed state, is 3-15 mm. For some applications, a distance d7, measured parallel to axis ax1, between coupling point 52 and first end 72 of strut 70 while assembly 22 is in its expanded state, is 1-5 mm (e.g., 1-4 mm).

For some applications, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For some applications, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some applications, and as shown, in the expanded state, first end 72 of strut 70 is disposed closer to the downstream end of frame assembly 22 than is coupling point 52. For some applications, in the expanded state, first end 72 of strut 70 is disposed further from the downstream end of frame assembly 22 than is coupling point 52.

For applications in which frame assembly 22 comprises a plurality of legs 50 and a plurality of coupling points 52 (e.g., for applications in which the frame assembly comprises outer frame 60) expansion of the frame assembly increases a circumferential distance between adjacent coupling points 52, and an increase in a circumferential distance between adjacent legs 50. FIG. 3A shows such an increase in the circumferential distance between adjacent coupling points 52, from a circumferential distance d8 in the compressed state to a circumferential distance d9 in the expanded state. For some applications, distance d8 is 1-6 mm. For some applications, distance d9 is 3-15 mm.

For some applications, in addition to being coupled via ring 66 (e.g., struts 70 thereof) legs 50 are also connected to each other via connectors 78. Connectors 78 allow the described movement of legs 50 during expansion of frame assembly 22, but typically stabilize legs 50 relative to each other while the frame assembly is in its expanded state. For example, connectors 78 may bend and/or deflect during expansion of the frame assembly.

FIGS. 3B-C show structural changes in valve frame 30 during the transitioning of frame assembly 22 between its compressed and expanded states. Tubular portion 32 of valve frame 30 is defined by a plurality of cells 80, which are defined by the repeating pattern of the valve frame. When frame assembly 22 is expanded from its compressed state toward its expanded state, cells 80 (i) widen from a width d10 to a width d11 (measured orthogonal to axis ax1 of the frame assembly), and (ii) shorten from a height d12 to a height d13 (measured parallel to axis ax1 of the frame assembly). This shortening reduces the overall height (i.e., a longitudinal length between upstream end 34 and downstream end 36) of tubular portion 32 from a height d22 to a height d23, and thereby causes the above-described longitudinal movement of upstream support portion 40 toward coupling points 52 by a distance d14 (shown in FIG. 3C). For some applications, and as shown, coupling points 52 are disposed at the widest part of each cell.

Due to the configurations described herein, the distance by which flanges 54 move with respect to (e.g., toward, or toward-and-beyond) upstream support portion 40 (e.g., arms 46 thereof), is typically greater than the reduction in the overall height of tubular portion 32 (e.g., more than 20 percent greater, such as more than 30 percent greater, such as more than 40 percent greater). That is, implant 20 comprises:

    • a valve frame (30) that comprises a tubular portion (32) that circumscribes a longitudinal axis (ax1) of the valve frame so as to define a lumen (38) along the axis, the tubular portion having an upstream end (34), a downstream end (36), a longitudinal length therebetween, and a diameter (e.g., d1 or d2) transverse to the longitudinal axis;
    • a valve member (58), coupled to the tubular portion, disposed within the lumen, and arranged to provide unidirectional upstream-to-downstream flow of blood through the lumen;
    • an upstream support portion (40), coupled to the tubular portion; and
    • an outer frame (60), coupled to the tubular portion, and comprising a tissue-engaging flange (54),

wherein:

    • the implant has a first state (e.g., as shown in FIG. 2D and FIG. 4D) and a second state (e.g., as shown in FIG. 2E and FIG. 4E),
    • in both the first state and the second state, (i) the upstream support portion extends radially outward from the tubular portion, and (ii) the tissue-engaging flange extends radially outward from the tubular portion, and
    • the tubular portion, the upstream support portion, and the outer frame are arranged such that transitioning of the implant from the first state toward the second state:
      • increases the diameter of the tubular portion by a diameter-increase amount (e.g., the difference between d1 and d2),
      • decreases the length of the tubular portion by a length-decrease amount (e.g., the difference between d22 and d23), and
      • moves the flange a longitudinal distance with respect to (e.g., toward or toward-and-beyond) the upstream support portion (e.g., the difference between d3 and d4), this distance being greater than the length-decrease amount.

As shown in the figures, valve frame 30 is typically coupled to outer frame 60 by coupling between (i) a valve-frame coupling element 31 defined by valve frame 30, and (ii) an outer-frame coupling element 61 defined by outer frame 60 (e.g., an outer-frame coupling element is coupled to end 74 of each strut). Typically, elements 31 and 61 are fixed with respect to each other. Each coupling point 52 is thereby typically defined as the point at which a valve-frame coupling element and a corresponding outer-frame coupling element 61 are coupled (e.g., are fixed with respect to each other). For some applications, and as shown, elements 31 and 61 are eyelets configured to be coupled together by a connector, such as a pin or suture. Alternatively or additionally, elements 31 and 61 are soldered or welded together. For example, elements 31 and 61 may be coupled together by a pin that passes through the eyelets, and is welded in place.

Typically, and as shown, valve-frame coupling elements 31 are defined by tubular portion 32, and are disposed circumferentially around central longitudinal axis ax1. Outer-frame coupling elements 61 are coupled to ring 66 (or defined by frame 60, such as by ring 66) at respective peaks 64.

As shown (e.g., in FIGS. 2A-E), valve frame 30 (e.g., tubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof) are arranged in a close-fitting coaxial arrangement, in both the expanded and compressed states of frame assembly 22. Ignoring spaces due to the cellular structure of the frames, a radial gap d19 between valve frame 30 (e.g., tubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof) is typically less than 2 mm (e.g., less than 1 mm), in both the compressed and expanded states, and during the transition therebetween. This is facilitated by the coupling between frames 30 and 60, and the behavior, described hereinabove, of frame 60 in response to changes in the diameter of tubular portion 32 (e.g., rather than solely due to delivery techniques and/or tools). For some applications, more than 50 percent (e.g., more than 60 percent) of ring 66 is disposed within 2 mm of tubular portion 32 in both the compressed and expanded states, and during the transition therebetween. For some applications, more than 50 percent (e.g., more than 60 percent) of outer frame 60, except for flanges 54, is disposed within 2 mm of tubular portion 32 in both the compressed and expanded states, and during the transition therebetween.

The structural changes to frame assembly 22 (e.g., to outer frame 60 thereof) are described hereinabove as they occur during (e.g., as a result of) expansion of the frame assembly (in particular tubular portion 32 thereof). This is the natural way to describe these changes because, as described hereinbelow with respect to FIGS. 4A-6, assembly 22 is in its compressed state during percutaneous delivery to the implant site, and is subsequently expanded. However, the nature of implant 20 may be further understood by describing structural changes that occur during compression of the frame assembly (e.g., a transition from the expanded state in FIG. 2E to the intermediate state in FIG. 2D), in particular tubular portion 32 thereof (including if tubular portion 32 were compressed by application of compressive force to the tubular portion, and not to frame 60 except via the tubular portion pulling frame 60 radially inward). Such descriptions may also be relevant because implant 20 is typically compressed (i.e., “crimped”) soon before its percutaneous delivery, and therefore these changes may occur while implant 20 is in the care of the operating physician.

For some applications, the fixation of peaks 64 to respective sites of tubular portion 32 is such that compression of the tubular portion from its expanded state toward its compressed state such that the respective sites of the tubular portion pull the peaks radially inward via radially-inward tension on coupling points 52: (i) reduces a circumferential distance between each of the coupling points and its adjacent coupling points (e.g., from d9 to d8), and (ii) increases the amplitude of the pattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of outer-frame coupling elements 61 to valve-frame coupling elements 31 is such that compression of tubular portion 32 from its expanded state toward its compressed state such that the valve-frame coupling elements pull the outer-frame coupling elements radially inward: (i) reduces a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements (e.g., from d9 to d8), and (ii) increases the amplitude of the pattern of ring 66 (e.g., from d21 to d20).

For some applications, the fixation of peaks 64 to the respective sites of tubular portion 32 is such that compression of the tubular portion from its expanded state toward its compressed state (i) pulls the peaks radially inward via radially-inward pulling of the respective sites of the tubular portion on the peaks, (ii) reduces a circumferential distance between each of coupling points 52 and its adjacent coupling points (e.g., from d9 to d8), and (iii) increases the amplitude of the pattern of ring 66 (e.g., from d21 to d20), without increasing radial gap d19 between valve frame 30 (e.g., tubular portion 32 thereof) and the ring by more than 1.5 mm.

For some applications, the fixation of outer-frame coupling elements 61 with respect to valve-frame coupling elements 31 is such that compression of tubular portion 32 from its expanded state toward its compressed state (i) pulls outer-frame coupling elements 61 radially inward via radially-inward pulling of valve-frame coupling elements 31 on outer-frame coupling elements 61, (ii) reduces a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements (e.g., from d9 to d8), and (iii) increases the amplitude of the pattern of ring 66 (e.g., from d21 to d20), without increasing radial gap d19 between valve frame 30 (e.g., tubular portion 32 thereof) and the ring by more than 1.5 mm.

Reference is made to FIGS. 4A-F, which are schematic illustrations of implantation of implant 20 at a native valve 10 of a heart 4 of a subject, in accordance with some applications of the invention. Valve 10 is shown as a mitral valve of the subject, disposed between a left atrium 6 and a left ventricle 8 of the subject. However, implant 20 may be implanted at another heart valve of the subject, mutatis mutandis. Similarly, although FIGS. 4A-F show implant 20 being delivered transseptally via a sheath 88, the implant may alternatively be delivered by any other suitable route, such as transatrially, or transapically.

Implant 20 is delivered, in its compressed state, to native valve 10 using a delivery tool 89 that is operable from outside the subject (FIG. 4A). Typically, implant 20 is delivered within a delivery capsule 90 of tool 89, which retains the implant in its compressed state. Delivery capsule 90 is disposed at a distal end of tool 89. A transseptal approach, such as a transfemoral approach, is shown. Typically, implant 20 is positioned such that at least flanges 54 are disposed downstream of the native valve (i.e., within ventricle 8). At this stage, frame assembly 22 of implant 20 is as shown in FIG. 2A.

Subsequently, flanges 54 are allowed to protrude radially outward, as described hereinabove, e.g., by releasing them from capsule 90 (FIG. 4B). For example, and as shown, capsule 90 may comprise a distal capsule-portion 92 and a proximal capsule-portion 94, and the distal capsule-portion may be moved distally with respect to implant 20, so as to expose flanges 54. At this stage, frame assembly 22 of implant 20 is as shown in FIG. 2B.

Subsequently, implant 20 is moved upstream, such that upstream support portion 40, in its compressed state, is disposed upstream of leaflets 12 (i.e., within atrium 6). For some applications, the upstream movement of implant 20 causes flanges 54 to engage leaflets 12. However, because of the relatively large distance d3 provided by implant 20 (described hereinabove), for some applications it is not necessary to move the implant so far upstream that flanges 54 tightly engage leaflets 12 and/or pull the leaflets upstream of the valve annulus. Upstream support portion 40 is then allowed to expand such that it protrudes radially outward, as described hereinabove, e.g., by releasing it from capsule 90 (FIG. 4D). For example, and as shown, proximal capsule-portion 94 may be moved proximally with respect to implant 20, so as to expose upstream support portion 40. At this stage, frame assembly 22 of implant 20 is as shown in FIG. 2D, in which: (i) distance d3 exists between upstream support portion 40 and flanges 54, (ii) the flanges have span d15, (iii) the upstream support portion has span d17, and (iv) tubular portion 32 has diameter d1.

Typically, expansion of frame assembly 22 is inhibited by distal capsule-portion 92, e.g., by inhibiting expansion of tubular portion 32. For example, a downstream region 33 of frame assembly 22, downstream of flanges 54, may remain compressed within distal capsule-portion 92. Alternatively or additionally, the expansion may be inhibited by another portion of delivery tool 89 (e.g., a portion of the delivery tool that is disposed within lumen 38).

Subsequently, implant 20 is allowed to expand toward its expanded state, such that tubular portion 32 widens to diameter d2, and the distance between upstream support portion 40 and flanges 54 reduces to distance d4 (FIG. 4E). This is typically achieved by deploying downstream region 33 from capsule-portion 92. This expansion sandwiches tissue of valve 10 (typically including annular tissue and/or leaflets 12) between upstream support portion 40 and flanges 54, thereby securing implant 20 at the valve. FIG. 4F shows delivery capsule 90 having been removed from the body of the subject, leaving implant 20 in place at valve 10.

As described hereinabove, implant 20 is configured such that when tubular portion 32 is expanded, flanges 54 and upstream support portion 40 move a relatively large distance toward each other. This enables distance d3 to be relatively large, while distance d4 is sufficiently small to provide effective anchoring. As also described hereinabove, implant 20 is configured such that flanges 54 and upstream support portion 40 can extend radially outward a relatively large distance while tubular portion 32 remains compressed. It is hypothesized that for some applications, these configurations (independently and/or together) facilitate effective anchoring of implant 20, by facilitating placement of a relatively large proportion of valve tissue (e.g., leaflets 12) between the flanges and the upstream support portion prior to expanding tubular portion 32 and sandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outward extension of flanges 54 and upstream support portion 40 prior to expansion of tubular portion 32, further facilitates the anchoring/sandwiching step by reducing radially-outward pushing of the valve tissue (e.g., leaflets 12) during the expansion of the tubular portion, and thereby increasing the amount of valve tissue that is sandwiched.

It is yet further hypothesized that this configuration of implant 20 facilitates identifying correct positioning of the implant (i.e., with upstream support portion 40 upstream of leaflets 12 and flanges 54 downstream of the leaflets) prior to expanding tubular portion 32 and sandwiching the valve tissue.

It is to be noted that the deployment of implant 20 is therefore achieved by:

    • unhousing a longitudinally-intermediate portion of the implant (to allow flanges 54 to expand), the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant;
    • subsequently, unhousing the longitudinally-proximal portion of the implant (to allow upstream support portion 40 to expand); and
    • subsequently, unhousing the longitudinally-distal portion of the implant (to allow the longitudinally-distal portion of the implant, typically including the tubular portion within which valve member 58 is disposed, to expand).

It is to be further noted that the deployment of implant 20 may be described with respect to delivery tool 89. For example:

    • distal capsule-portion 92 is moved distally with respect to the implant (to allow flanges 54 to expand);
    • subsequently, proximal capsule-portion 94 is moved proximally with respect to the implant (to allow upstream support portion 40 to expand); and
    • subsequently, distal capsule-portion 92 is again moved distally with respect to the implant (to allow the longitudinally distal portion of the implant, typically including the tubular portion within which valve member 58 is disposed, to expand).

For some applications, delivery tool 89 (e.g., an extracorporeal control portion 110 thereof, disposed at a proximal portion of the delivery tool) is configured to ensure that the operator follows the particular sequence of movement of capsule-portions 92 and 94 described. For example, control portion 110 may comprise a series of locks 114, each lock becoming unlockable only after the previous step in the sequence has been completed, the unlocking of the lock allowing the subsequent step in the sequence to be performed. For some such applications, control portion 110 may further comprise a series of controllers 112, via which the operator causes the movement of a respective capsule-portion for each respective step. An example of how control portion 110 may be used, in accordance with some applications of the invention, is as follows:

    • (1) Operator moves distal capsule-portion 92 distally with respect to implant 20 by actuating a first controller 112a. Once capsule-portion 92 has been moved a given distance, a first lock 114a automatically becomes unlockable (and typically capsule-portion 92 is prevented from moving further than the given distance).
    • (2) Operator unlocks lock 114a, and then moves proximal capsule-portion 94 proximally with respect to implant 20 by actuating a second controller 112b. Once capsule-portion 94 has been moved a given distance, a second lock 114b automatically becomes unlockable.
    • (3) Operator unlocks lock 114b, and then moves distal capsule-portion 92 further distally with respect to implant 20 by again actuating first controller 112a. Alternatively, control portion 110 may comprise a third controller (not shown) for this second movement of distal capsule-portion 92.

It is to be noted that throughout this patent application (including in the specification and in the claims) the term “unlockable” means able to be unlocked (rather than meaning not lockable).

Therefore, apparatus is provided, in accordance with some applications of the invention, the apparatus comprising an implant (e.g., implant 20) and a delivery tool (e.g., tool 89), the tool comprising:

(1) a delivery capsule, disposed at a distal portion of the tool, the delivery capsule comprising a proximal capsule-portion 94 dimensioned to house a first part of the implant, and a distal capsule-portion 92 dimensioned to house a second part of the implant; and

(2) an extracorporeal control portion 110, disposed at a proximal portion of the tool, the control portion comprising one or more controllers 112 and one or more locks 114, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the housed implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative such that:

    • in a first state of the tool:
      • a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated,
      • a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited,
      • a proximal movement of the proximal capsule-portion proximally with respect to the implant is inhibited, and
      • responsively to movement of the distal capsule-portion distally, the tool automatically unlocks a second state of the tool;
    • in the second state of the tool:
      • the proximal movement of the proximal capsule-portion is facilitated,
      • the second distal movement of the distal capsule-portion remains inhibited, and
      • responsively to movement of the proximal capsule-portion proximally, the tool automatically unlocks a third state of the tool; and
    • in the third state of the tool:
      • the second distal movement of the distal capsule-portion is facilitated.

For some applications, rather than having three states, tool 89 has two states. For clarity, these will be referred to as state A and state B. However, state A may be similar to the second state described hereinabove, mutatis mutandis. (State A may alternatively be called a primary state, and state B may alternatively be called a secondary state.) For applications in which tool 89 has two states, the tool typically has only one lock 114, the unlocking of which transitions the tool from state A to state B.

In state, A, it is possible to move distal capsule-portion 92 up to the first distance distally with respect to implant 20 (e.g., by actuating controller 112a), and to move proximal capsule-portion 94 proximally with respect to the implant (e.g., by actuating controller 112b), but it is not possible to move the distal capsule-portion further distally, which would deploy downstream region 33. Typically, in state A, it is also possible to return proximal capsule-portion 94 distally and distal capsule-portion 92 proximally. In state B, it is possible to move distal capsule-portion 92 further distally, thereby deploying downstream region 33. For some applications, lock 114 is not unlockable until distal capsule-portion 92 has been moved the first distance distally, and/or until proximal capsule-portion 94 has been moved proximally.

Therefore, apparatus is provided, in accordance with some applications of the invention, the apparatus comprising an implant and a delivery tool, the tool comprising:

    • a delivery capsule, disposed at a distal portion of the tool, the delivery capsule comprising a proximal capsule-portion dimensioned to house a first part of the implant, and a distal capsule-portion dimensioned to house a second part of the implant; and
    • an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion comprising one or more controllers and one or more locks, the controllers being operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers,

wherein the controllers and the locks are mechanically cooperative such that:

    • in a state A of the tool: (i) a first distal movement of the distal capsule-portion up to a first distance distally with respect to the implant is facilitated, (ii) a second distal movement of the distal capsule-portion further distally with respect to the implant is inhibited, and (iii) a proximal movement of the proximal capsule-portion proximally with respect to the implant is facilitated; and
    • in a state B of the tool, the second distal movement of the distal capsule-portion is facilitated.

As shown in FIG. 1A, for some applications, in the expanded state of frame assembly 22, implant 20 defines a toroidal space 49 between flanges 54 and upstream support portion 40 (e.g., a space that is wider than distance d4). For example, space 49 may have a generally triangular cross-section. It is hypothesized that for some such applications, in addition to sandwiching tissue of the native valve between upstream support portion 40 and flanges 54 (e.g., the tips of the flanges), space 49 advantageously promotes tissue growth therewithin (e.g., between leaflet tissue and covering 23), which over time further secures implant 20 within the native valve.

Reference is now made to FIG. 5, which is a schematic illustration of a step in the implantation of implant 20, in accordance with some applications of the invention. Whereas FIGS. 4A-F show an implantation technique in which flanges 54 are expanded prior to upstream support portion 40, for some applications the upstream support portion is expanded prior to the flanges. FIG. 5 shows a step in such an application.

Reference is again made to FIGS. 2A-5. As noted hereinabove, implant 20 may be implanted by causing flanges 54 to radially protrude before causing upstream support portion 40 to radially protrude, or may be implanted by causing the upstream support portion to protrude before causing the flanges to protrude. For some applications, implant 20 is thereby configured to be deliverable in a downstream direction (e.g., transseptally, as shown, or transapically) or in an upstream direction (e.g., transapically or via the aortic valve). Thus, for some applications, an operating physician may decide which delivery route is preferable for a given application (e.g., for a given subject, and/or based on available equipment and/or expertise), and implant 20 is responsively prepared for the chosen delivery route (e.g., by loading the implant into an appropriate delivery tool).

It is to be noted that for some applications, downstream delivery of implant 20 may be performed by expanding flanges 54 first (e.g., as shown in FIGS. 4A-F) or by expanding upstream support portion 40 first (e.g., as shown in FIG. 5). Similarly, for some applications upstream delivery of implant 20 may be performed by upstream support portion 40 first, or by expanding flanges 54 first.

Reference is now made to FIG. 6, which is a schematic illustration of implant 20, in the state and position shown in FIG. 4D, in accordance with some applications of the invention. For some applications, while implant 20 is in the state and position shown in FIG. 4D, leaflets 12 of valve 10 are able to move, at least in part in response to beating of the heart. Frame (A) shows leaflets 12 during ventricular systole, and frame (B) shows the leaflets during ventricular diastole. For some such applications, blood is thereby able to flow from atrium 6 to ventricle 8, between leaflets 12 and implant 20. It is hypothesized that this advantageously facilitates a more relaxed implantation procedure, e.g., facilitating retaining of implant 20 in this state and position for a duration of greater than 8 minutes. During this time, imaging techniques may be used to verify the position of implant 20, and/or positioning of leaflets 12 between upstream support portion 40 and flanges 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematic illustrations of frame assemblies 122 and 222 of respective implants, in accordance with some applications of the invention. Except where noted otherwise, frame assemblies 122 and 222 are typically identical to frame assembly 22, mutatis mutandis. Elements of frame assemblies 122 and 222 share the name of corresponding elements of frame assembly 22. Additionally, except where noted otherwise, the implants to which frame assemblies 122 and 222 belong are similar to implant 20, mutatis mutandis.

Frame assembly 122 comprises (i) a valve frame 130 that comprises a tubular portion 132 and an upstream support portion 140 that typically comprises a plurality of arms 146, and (ii) an outer frame (e.g., a leg frame) 160 that circumscribes the valve frame, and comprises a plurality of legs 150 that each comprise a tissue-engaging flange 154. Typically, outer frame 160 comprises a ring 166 to which legs 150 are coupled. Ring 166 is defined by a pattern of alternating peaks and troughs, the peaks being fixed to frame 130 at respective coupling points 152, e.g., as described hereinabove for frame assembly 22, mutatis mutandis.

Frame assembly 222 comprises (i) a valve frame 230 that comprises a tubular portion 232 and an upstream support portion 240 that typically comprises a plurality of arms 246, and (ii) an outer frame (e.g., a leg frame) 260 that circumscribes the valve frame, and comprises a plurality of legs 250 that each comprise a tissue-engaging flange 254. Typically, outer frame 260 comprises a ring 266 to which legs 250 are coupled. Ring 266 is defined by a pattern of alternating peaks and troughs, the peaks being fixed to frame 230 at respective coupling points 252, e.g., as described hereinabove for frame assembly 22, mutatis mutandis.

Whereas arms 46 of frame assembly 22 are shown as extending from upstream end 34 of tubular portion 32, arms 146 and 246 of frame assemblies 122 and 222, respectively, extend from sites further downstream. (This difference may also be made to frame assembly 22, mutatis mutandis.) Tubular portions 32, 132 and 232 are each defined by a repeating pattern of cells that extends around the central longitudinal axis. Typically, and as shown, tubular portions 32, 132 and 232 are each defined by two stacked, tessellating rows of cells. In the expanded state of each tubular portion, these cells are typically narrower at their upstream and downstream extremities than midway between these extremities. For example, and as shown, the cells may be roughly diamond or astroid in shape. In frame assembly 22, each arm 46 is attached to and extends from a site 35 that is at the upstream extremity of cells of the upstream row. In contrast, in frame assemblies 122 and 222, each arm 146 or 246 is attached to and extends from a site 135 (assembly 122) or 235 (assembly 222) that is at the connection between two adjacent cells of the upstream row (alternatively described as being at the upstream extremity of cells of the downstream row).

It is hypothesized by the inventors that this lower position of the arms, while maintaining the length of the lumen of the tubular portion, advantageously reduces the distance that the tubular portion (i.e., the downstream end thereof) extends into the ventricle of the subject, and thereby reduces a likelihood of inhibiting blood flow out of the ventricle through the left ventricular outflow tract. It is further hypothesized that this position of the arms reduces radial compression of the tubular portion by movement of the heart, due to greater rigidity of the tubular portion at sites 135 and 235 (which is supported by two adjacent cells) than at site 35 (which is supported by only one cell).

As shown, in the expanded state of frame assemblies 22, 122 and 222, the legs (50, 150 and 250, respectively) are circumferentially staggered with the arms of the upstream support portion (46, 146 and 246, respectively). This allows the legs to move in an upstream direction between the arms during expansion of the tubular portion (32, 132 and 232, respectively), facilitating application of greater sandwiching force on tissue of the native valve. The lower position of the arms of assemblies 122 and 222 includes circumferentially shifting the position of the arms by the width of half a cell. In order to maintain the circumferential staggering of the arms and legs, rings 166 and 266 (and thereby legs 150 and 250) are circumferentially shifted correspondingly. As a result, whereas the peaks of ring 66 generally align with connections between adjacent cells of the downstream row of cells of tubular portion 32 (and are fixed to these sites), the peaks of rings 166 and 266 are generally aligned midway between these sites (i.e., at spaces of the cellular structure of the tubular portion). Appendages 168 (for assembly 122) or 268 (for assembly 222) facilitate fixing of the peak with respect to the tubular structure.

For assembly 122, appendages 168 are defined by valve frame 130 (e.g., by tubular portion 132 thereof) and extend (in a downstream direction) to the peaks of ring 166, to which they are fixed. For example, each appendage 168 may define a valve-frame coupling element 131 that is fixed to a respective outer-frame coupling element 161 defined by outer frame 260. Typically, appendages 168 extend from sites 135. Typically, appendages 168 are integral with tubular portion 132 and/or in-plane with the tubular portion (e.g., are part of its tubular shape).

For assembly 222, appendages 268 are defined by outer frame 260, and extend (e.g., in an upstream direction) from the peaks of ring 266. Typically, appendages 268 extend to sites 235, to which they are fixed. For example, each appendage 268 may define an outer-frame coupling element 261 that is fixed to a respective valve-frame coupling element 231 defined by valve frame 230 (e.g., by tubular portion 232 thereof). Typically, appendages 268 are integral with outer frame 260 and/or in-plane with adjacent portions of outer frame 260, such as ring 266.

Therefore, frame assembly 122 defines a hub at site 135, and frame assembly 222 defines a hub at site 235. For some applications, apparatus therefore comprises:

    • a plurality of prosthetic valve leaflets; and
    • a frame assembly, comprising:
      • a tubular portion (132 or 232) defined by a repeating pattern of cells, the tubular portion extending circumferentially around longitudinal axis ax1 so as to define a longitudinal lumen, the prosthetic valve leaflets coupled to the inner frame and disposed within the lumen;
      • an outer frame (160 or 260), comprising a plurality of legs (150 or 250), distributed circumferentially around the tubular portion, each leg having a tissue-engaging flange (154 or 254);
      • an upstream support portion (140 or 240) that comprises a plurality of arms (146 or 246) that extend radially outward from the tubular portion; and
      • a plurality of appendages (168 or 268), each having a first end that defines a coupling element (161 or 261) via which the tubular portion is coupled to the outer frame, and a second end;

wherein the frame assembly defines a plurality of hubs (135 or 235), distributed circumferentially around the longitudinal axis on a plane that is transverse to longitudinal axis ax1, each hub defined by convergence and connection of, (i) two adjacent cells of the tubular portion, (ii) an arm of the plurality of arms, and (iii) an appendage of the plurality of appendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of an implant 320 comprising a frame assembly 322, in accordance with some applications of the invention. Except where noted otherwise, frame assembly 322 is identical to frame assembly 122, and implant 300 is identical to the implant to which frame assembly 122 belongs, mutatis mutandis. FIG. 9A is a side-view of implant 320, and FIG. 9B is an isometric bottom-view of the implant.

Frame assembly 122 comprises (i) a valve frame 330 that comprises a tubular portion 332 and an upstream support portion 340 that typically comprises a plurality of arms 346, and (ii) an outer frame (e.g., a leg frame) 360 that circumscribes the valve frame, and comprises a plurality of legs 350 that each comprise a tissue-engaging flange 354. Typically, outer frame 360 comprises a ring 366 to which legs 350 are coupled. Ring 366 is defined by a pattern of alternating peaks and troughs, the peaks being fixed to frame 330 at respective coupling points 352, e.g., as described hereinabove for frame assembly 22 and/or frame assembly 122, mutatis mutandis.

Frame assembly 322 comprises an annular upstream support portion 340 that has an inner portion 342 that extends radially outward from the upstream portion (e.g., the upstream end) of tubular portion 332. Upstream support portion 340 further comprises one or more fabric pockets 344 disposed circumferentially around inner portion 342, each pocket of the one or more pockets having an opening that faces a downstream direction (i.e., generally toward the downstream end of implant 320). In the figures, upstream support portion 340 has a single toroidal pocket 344 that extends circumferentially around inner portion 342.

Typically, a covering 323 (e.g., similar to covering 23, described hereinabove, mutatis mutandis) is disposed over arms 346, thereby forming pocket 344. Further typically, arms 346 are shaped to form pocket 344 from covering 323. For example, and as shown, arms 346 may curve to form a hook-shape.

For some applications, portion 340 has a plurality of separate pockets 344, e.g., separated at arms 346. For some such applications, covering 323 is loosely-fitted (e.g., baggy) between radially-outward parts of arms 346, e.g., compared to inner portion 342, in which the covering is more closely-fitted between radially-inward parts of the arms.

FIG. 9C shows implant 320 implanted at native valve 10. Pocket 344 is typically shaped and arranged to billow in response to perivalvular flow 302 of blood in an upstream direction. If ventricular systole forces blood in ventricle 8 between implant 320 and native valve 10, that blood inflates pocket 344 and presses it (e.g., covering 323 and/or the radially-outward part of arm 346) against tissue of atrium 6 (e.g., against the atrial wall), thereby increasing sealing responsively. It is hypothesized by the inventors that the shape and orientation of pocket 344 (e.g., the hook-shape of arms 346) facilitates this pressing radially-outward in response to the pocket's receipt of upstream-flowing blood.

Pocket(s) 344 may be used in combination with any of the implants described herein, mutatis mutandis.

Reference is again made to FIGS. 1A-9C. It is to be noted that unless specifically stated otherwise, the term “radially outward” (e.g., used to describe upstream support portion 40 and flanges 54) means portions of the element are disposed progressively further outward from a central point (such as longitudinal axis ax1 or tubular portion 32), but does not necessarily mean disposed at 90 degrees with respect to longitudinal axis ax1. For example, flanges 54 may extend radially outward at 90 degrees with respect to longitudinal axis ax1, but may alternatively extend radially outward at a shallower angle with respect to the longitudinal axis.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

1. A method, comprising: wherein:

percutaneously advancing an implant to a native heart valve of a subject, the implant housed in a compressed state within a delivery tool;
unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant;
subsequently, unhousing the longitudinally-proximal portion of the implant; and
subsequently, unhousing the longitudinally-distal portion of the implant,
unhousing the longitudinally-intermediate portion of the implant comprises unhousing flanges of the implant such that the flanges automatically expand, and such that upon the flanges expanding a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction.

2. The method according to claim 1, wherein:

unhousing the longitudinally-proximal portion of the implant comprises unhousing an upstream support portion of the implant such that the upstream support portion automatically expands; and
unhousing the longitudinally-distal portion of the implant comprises unhousing the longitudinally-distal portion of the implant such that the longitudinally-distal portion of the implant automatically expands.

3. The method according to claim 2, wherein the longitudinally-distal portion includes a tubular portion within which a valve member is disposed, and wherein unhousing the longitudinally-distal portion of the implant comprises unhousing the longitudinally-distal portion of the implant such that the tubular portion expands to form a lumen and the valve member regulates one-way flow of blood through the lumen.

4. The method according to claim 3, wherein unhousing the longitudinally-distal portion of the implant comprises facilitating expansion of the implant such that the tubular portion expands and the flanges become longitudinally closer to the upstream support portion.

5. The method according to claim 4, wherein facilitating expansion of the implant comprises sandwiching leaflets of the native heart valve between the flanges and the upstream support portion.

6. The method according to claim 1, wherein:

percutaneously advancing the implant to the native heart valve comprises advancing the implant housed within a capsule of the delivery tool, the capsule having a distal capsule-portion and a proximal capsule-portion,
unhousing the longitudinally-intermediate portion of the implant comprises unhousing the longitudinally-intermediate portion from within the distal capsule-portion by moving the distal capsule-portion distally with respect to the implant,
unhousing the longitudinally-proximal portion comprises unhousing the longitudinally-proximal portion from within the proximal capsule-portion by moving the proximal capsule-portion proximally with respect to the implant, and
unhousing the longitudinally-distal portion of the implant comprises deploying the longitudinally-distal portion of the implant from the distal capsule-portion.

7. The method according to claim 6, wherein deploying the longitudinally-distal portion of the implant from the distal capsule-portion comprises additionally moving the distal capsule-portion distally with respect to the implant.

8. Apparatus, comprising:

an implant for implantation at a native valve of a heart of a subject, the implant comprising a valve frame assembly comprising: a tubular portion having an upstream end and a downstream end that defines, in part, a longitudinally-distal portion of the implant; an upstream support portion, extending from the upstream end of the tubular portion, the upstream portion defining a longitudinally-proximal portion of the implant; and a plurality of tissue-engaging flanges coupled to the tubular portion at respective coupling points, the plurality of flanges defining a longitudinally-intermediate portion of the implant; and
a delivery tool: comprising a delivery capsule dimensioned (i) to house and retain the implant in a compressed state of the implant in which (a) the tubular portion is in a constrained-tubular-portion state, (b) the upstream support portion is in a constrained-upstream-support-portion state, and (c) the plurality of flanges are in a constrained-flange state, and (ii) to be advanced percutaneously to the heart of the subject while the implant is housed and in the compressed state, and operable from outside the subject to: transition the implant from the compressed state into an intermediate state of the implant by (1) unhousing the longitudinally-intermediate portion, while retaining the tubular portion in the constrained-tubular-portion state, and (2) subsequently, unhousing the longitudinally-proximal portion of the implant, while retaining at least the longitudinally-distal portion of the implant in a constrained state, and subsequently, unhouse the longitudinally-distal portion of the implant such that the implant assumes an expanded state, such that in the expanded state a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction.

9. The apparatus according to claim 8, wherein:

the upstream support portion is configured such that, upon the implant entering the intermediate state, the upstream support portion is expanded into a released-upstream-support-portion state.

10. The apparatus according to claim 8, wherein the tubular portion is configured such that, upon the implant transitioning from the intermediate state to the expanded state, the tubular portion expands and thereby moves the plurality of flanges longitudinally closer to the upstream support portion.

11. The apparatus according to claim 8, wherein the tubular member comprises a valve member, and wherein, in the expanded state of the implant, the tubular portion defines a lumen therethrough, and the valve member is configured to regulate one-way flow of blood through the lumen.

12. The apparatus according to claim 8, wherein the capsule of the delivery tool comprises a distal capsule-portion and a proximal capsule-portion, and wherein the capsule is configured such that:

upon the implant entering the intermediate state, (i) the distal capsule-portion is moved distally with respect to the implant to unhouse the longitudinally-intermediate portion of the implant, while still surrounding the longitudinally-distal portion of the implant, and (ii) the proximal capsule-portion is moved proximally with respect to the implant to unhouse the longitudinally-proximal portion, and
upon the implant entering the expanded state, the distal capsule-portion is moved further distally with respect to the implant to unhouse the longitudinally-distal portion of the implant.

13. A method, comprising: wherein:

percutaneously advancing an implant to a native heart valve of a subject, the implant housed in a compressed state within a delivery tool;
unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant;
subsequently, unhousing the longitudinally-proximal portion of the implant; and
subsequently, unhousing the longitudinally-distal portion of the implant,
unhousing the longitudinally-intermediate portion of the implant comprises unhousing flanges of the implant such that the flanges automatically expand;
unhousing the longitudinally-proximal portion of the implant comprises unhousing an upstream support portion of the implant such that the upstream support portion automatically expands; and
unhousing the longitudinally-distal portion of the implant comprises unhousing the longitudinally-distal portion of the implant such that the longitudinally-distal portion of the implant automatically expands,
wherein the longitudinally-distal portion includes a tubular portion within which a valve member is disposed, and wherein unhousing the longitudinally-distal portion of the implant comprises unhousing the longitudinally-distal portion of the implant such that the tubular portion expands to form a lumen and the valve member regulates one-way flow of blood through the lumen, and
wherein unhousing the longitudinally-distal portion of the implant comprises facilitating expansion of the implant such that the tubular portion expands and the flanges become longitudinally closer to the upstream support portion.

14. A method, comprising: wherein:

percutaneously advancing an implant to a native heart valve of a subject, the implant housed in a compressed state within a delivery tool;
unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant;
subsequently, unhousing the longitudinally-proximal portion of the implant; and
subsequently, unhousing the longitudinally-distal portion of the implant,
percutaneously advancing the implant to the native heart valve comprises advancing the implant housed within a capsule of the delivery tool, the capsule having a distal capsule-portion and a proximal capsule-portion,
unhousing the longitudinally-intermediate portion of the implant comprises unhousing the longitudinally-intermediate portion from within the distal capsule-portion by moving the distal capsule-portion distally with respect to the implant,
unhousing the longitudinally-proximal portion comprises unhousing the longitudinally-proximal portion from within the proximal capsule-portion by moving the proximal capsule-portion proximally with respect to the implant, and
unhousing the longitudinally-distal portion of the implant comprises deploying the longitudinally-distal portion of the implant from the distal capsule-portion.

15. The method according to claim 14, wherein deploying the longitudinally-distal portion of the implant from the distal capsule-portion comprises additionally moving the distal capsule-portion distally with respect to the implant.

16. Apparatus, comprising:

an implant for implantation at a native valve of a heart of a subject, the implant comprising a valve frame assembly comprising: a tubular portion having an upstream end and a downstream end that defines, in part, a longitudinally-distal portion of the implant; an upstream support portion, extending from the upstream end of the tubular portion, the upstream portion defining a longitudinally-proximal portion of the implant; and a plurality of tissue-engaging flanges coupled to the tubular portion at respective coupling points, the plurality of flanges defining a longitudinally-intermediate portion of the implant; and
a delivery tool: comprising a delivery capsule dimensioned (i) to house and retain the implant in a compressed state of the implant in which (a) the tubular portion is in a constrained-tubular-portion state, (b) the upstream support portion is in a constrained-upstream-support-portion state, and (c) the plurality of flanges are in a constrained-flange state, and (ii) to be advanced percutaneously to the heart of the subject while the implant is housed and in the compressed state, and operable from outside the subject to: transition the implant from the compressed state into an intermediate state of the implant by (1) unhousing the longitudinally-intermediate portion, while retaining the tubular portion in the constrained-tubular-portion state, and (2) subsequently, unhousing the longitudinally-proximal portion of the implant, while retaining at least the longitudinally-distal portion of the implant in a constrained state, and subsequently, unhouse the longitudinally-distal portion of the implant such that the implant assumes an expanded state,
wherein the tubular portion is configured such that, upon the implant transitioning from the intermediate state to the expanded state, the tubular portion expands and thereby moves the plurality of flanges longitudinally closer to the upstream support portion.

17. Apparatus, comprising:

an implant for implantation at a native valve of a heart of a subject, the implant comprising a valve frame assembly comprising: a tubular portion having an upstream end and a downstream end that defines, in part, a longitudinally-distal portion of the implant; an upstream support portion, extending from the upstream end of the tubular portion, the upstream portion defining a longitudinally-proximal portion of the implant; and a plurality of tissue-engaging flanges coupled to the tubular portion at respective coupling points, the plurality of flanges defining a longitudinally-intermediate portion of the implant; and
a delivery tool: comprising a delivery capsule dimensioned (i) to house and retain the implant in a compressed state of the implant in which (a) the tubular portion is in a constrained-tubular-portion state, (b) the upstream support portion is in a constrained-upstream-support-portion state, and (c) the plurality of flanges are in a constrained-flange state, and (ii) to be advanced percutaneously to the heart of the subject while the implant is housed and in the compressed state, and operable from outside the subject to: transition the implant from the compressed state into an intermediate state of the implant by (1) unhousing the longitudinally-intermediate portion, while retaining the tubular portion in the constrained-tubular-portion state, and (2) subsequently, unhousing the longitudinally-proximal portion of the implant, while retaining at least the longitudinally-distal portion of the implant in a constrained state, and subsequently, unhouse the longitudinally-distal portion of the implant such that the implant assumes an expanded state,
wherein the capsule of the delivery tool comprises a distal capsule-portion and a proximal capsule-portion, and wherein the capsule is configured such that:
upon the implant entering the intermediate state, (i) the distal capsule-portion is moved distally with respect to the implant to unhouse the longitudinally-intermediate portion of the implant, while still surrounding the longitudinally-distal portion of the implant, and (ii) the proximal capsule-portion is moved proximally with respect to the implant to unhouse the longitudinally-proximal portion, and
upon the implant entering the expanded state, the distal capsule-portion is moved further distally with respect to the implant to unhouse the longitudinally-distal portion of the implant.
Referenced Cited
U.S. Patent Documents
3604488 September 1971 Wishart et al.
3656185 April 1972 Carpentier
3840018 October 1974 Heifetz
3874388 April 1975 King et al.
3898701 August 1975 La Russa
4042979 August 23, 1977 Angell
4118805 October 10, 1978 Reimels
4214349 July 29, 1980 Munch
4222126 September 16, 1980 Boretos et al.
4261342 April 14, 1981 Aranguren
4275469 June 30, 1981 Gabbay
4340091 July 20, 1982 Skelton et al.
4423525 January 3, 1984 Vallana et al.
4434828 March 6, 1984 Trincia
4473928 October 2, 1984 Johnson
4602911 July 29, 1986 Ahmadi et al.
4625727 December 2, 1986 Leiboff
4712549 December 15, 1987 Peters et al.
4778468 October 18, 1988 Hunt et al.
4853986 August 8, 1989 Allen
4892541 January 9, 1990 Alonso
4917698 April 17, 1990 Carpenter et al.
4961738 October 9, 1990 Mackin
4972494 November 20, 1990 White et al.
4994077 February 19, 1991 Dobben
5061277 October 29, 1991 Carpentier et al.
5078739 January 7, 1992 Martin
5104407 April 14, 1992 Lam et al.
5108420 April 28, 1992 Marks
5201757 April 13, 1993 Heyn et al.
5201880 April 13, 1993 Wright
5258008 November 2, 1993 Wilk
5300034 April 5, 1994 Behnke
5306296 April 26, 1994 Wright et al.
5314473 May 24, 1994 Godin
5325845 July 5, 1994 Adair
5332402 July 26, 1994 Teitelbaum
5397351 March 14, 1995 Pavenik et al.
5405378 April 11, 1995 Strecker
5443500 August 22, 1995 Sigwart
5450860 September 19, 1995 O'Connor
5473812 December 12, 1995 Morris et al.
5477856 December 26, 1995 Lundquist
5601572 February 11, 1997 Middleman et al.
5607444 March 4, 1997 Lam
5607470 March 4, 1997 Milo
5626609 May 6, 1997 Zvenyatsky et al.
5647857 July 15, 1997 Anderson et al.
5669919 September 23, 1997 Sanders et al.
5674279 October 7, 1997 Wright et al.
5683402 November 4, 1997 Cosgrove et al.
5702397 December 30, 1997 Goble et al.
5702398 December 30, 1997 Tarabishy
5709695 January 20, 1998 Northrup, III
5713948 February 3, 1998 Uflacker
5716370 February 10, 1998 Williamson et al.
5716397 February 10, 1998 Myers
5716417 February 10, 1998 Girard et al.
5728116 March 17, 1998 Rosenman
5730150 March 24, 1998 Peppel et al.
5741297 April 21, 1998 Simon
5749371 May 12, 1998 Zadini et al.
5765682 June 16, 1998 Bley et al.
5776140 July 7, 1998 Cottone
5810882 September 22, 1998 Bolduc
5824066 October 20, 1998 Gross
5830221 November 3, 1998 Stein et al.
5843120 December 1, 1998 Israel et al.
5855614 January 5, 1999 Stevens et al.
5868777 February 9, 1999 Lam
5873906 February 23, 1999 Lau et al.
5876373 March 2, 1999 Giba et al.
5935098 August 10, 1999 Blaisdell et al.
5954766 September 21, 1999 Zadno-Azizi et al.
5957949 September 28, 1999 Leonhardt et al.
5957953 September 28, 1999 DiPoto et al.
5961440 October 5, 1999 Schweich et al.
5961539 October 5, 1999 Northrup, III et al.
5980565 November 9, 1999 Jayaraman
5984959 November 16, 1999 Robertson
6010530 January 4, 2000 Goicoechea
6019787 February 1, 2000 Richard et al.
6042554 March 28, 2000 Rosenman
6042607 March 28, 2000 Williamson, IV
6045497 April 4, 2000 Schweich et al.
6050936 April 18, 2000 Schweich et al.
6059715 May 9, 2000 Schweich et al.
6059827 May 9, 2000 Fenton
6074401 June 13, 2000 Gardiner et al.
6074417 June 13, 2000 Peredo
6102945 August 15, 2000 Campbell
6106550 August 22, 2000 Magovern
6110200 August 29, 2000 Hinnenkamp
6113612 September 5, 2000 Swanson et al.
6120534 September 19, 2000 Ruiz
6126686 October 3, 2000 Badylak et al.
6143024 November 7, 2000 Campbell et al.
6152937 November 28, 2000 Peterson et al.
6159240 December 12, 2000 Sparer
6165119 December 26, 2000 Schweich et al.
6165183 December 26, 2000 Kuehn et al.
6165210 December 26, 2000 Lau et al.
6174332 January 16, 2001 Loch
6183411 February 6, 2001 Mortier et al.
6187020 February 13, 2001 Zegdi et al.
6187040 February 13, 2001 Wright
6193686 February 27, 2001 Estrada et al.
6193745 February 27, 2001 Fogarty et al.
6315784 November 13, 2001 Djurovic
6217610 April 17, 2001 Carpentier et al.
6231602 May 15, 2001 Carpentier et al.
6251092 June 26, 2001 Qin et al.
6254609 July 3, 2001 Vrba et al.
6264700 July 24, 2001 Kilcoyne et al.
6287339 September 11, 2001 Vasquez et al.
6296656 October 2, 2001 Bodluc et al.
6312465 November 6, 2001 Griffin et al.
6319281 November 20, 2001 Patel
6332893 December 25, 2001 Mortier et al.
6334873 January 1, 2002 Lane et al.
6346074 February 12, 2002 Roth
6350278 February 26, 2002 Lenker et al.
6352561 March 5, 2002 Leopold et al.
6391036 May 21, 2002 Berg et al.
6402780 June 11, 2002 Williamson, IV
6406420 June 18, 2002 McCarthy et al.
6406493 June 18, 2002 Tu et al.
6409755 June 25, 2002 Vrba
6419696 July 16, 2002 Ortiz et al.
6428550 August 6, 2002 Vargas et al.
6440164 August 27, 2002 Dimatteo et al.
6451054 September 17, 2002 Stevens
6454799 September 24, 2002 Schreck
6458153 October 1, 2002 Bailey et al.
6461366 October 8, 2002 Seguin
6470892 October 29, 2002 Forsell
6478807 November 12, 2002 Foreman et al.
6482228 November 19, 2002 Norred
6491711 December 10, 2002 Durcan
6503274 January 7, 2003 Howanec et al.
6511491 January 28, 2003 Grudem et al.
6524338 February 25, 2003 Gundry
6530952 March 11, 2003 Vesely
6533772 March 18, 2003 Sherts et al.
6537314 March 25, 2003 Langberg et al.
6540782 April 1, 2003 Snyders
6547801 April 15, 2003 Dargent et al.
6551350 April 22, 2003 Thornton et al.
6554845 April 29, 2003 Fleenor et al.
6558396 May 6, 2003 Inoue
6558418 May 6, 2003 Carpentier et al.
6564805 May 20, 2003 Garrison et al.
6565603 May 20, 2003 Cox
6569196 May 27, 2003 Vesely
6569198 May 27, 2003 Wilson et al.
6579297 June 17, 2003 Bicek et al.
6582464 June 24, 2003 Gabbay
6589160 July 8, 2003 Schweich et al.
6602263 August 5, 2003 Swanson et al.
6602288 August 5, 2003 Cosgrove et al.
6602289 August 5, 2003 Colvin et al.
6613078 September 2, 2003 Barone
6613079 September 2, 2003 Wolinsky et al.
6616675 September 9, 2003 Evard et al.
6619291 September 16, 2003 Hlavka et al.
6626899 September 30, 2003 Houser et al.
6626917 September 30, 2003 Craig
6626930 September 30, 2003 Allen et al.
6629534 October 7, 2003 St. Goar et al.
6629921 October 7, 2003 Schweich et al.
6651671 November 25, 2003 Donlon et al.
6652556 November 25, 2003 VanTassel et al.
6669724 December 30, 2003 Park et al.
6682558 January 27, 2004 Tu et al.
6689125 February 10, 2004 Keith et al.
6689164 February 10, 2004 Seguin
6695866 February 24, 2004 Kuehn et al.
6699256 March 2, 2004 Logan et al.
6702826 March 9, 2004 Liddicoat et al.
6702846 March 9, 2004 Mikus et al.
6706065 March 16, 2004 Langberg et al.
6709456 March 23, 2004 Langberg et al.
6711444 March 23, 2004 Koblish
6716244 April 6, 2004 Klaco
6718985 April 13, 2004 Hlavka et al.
6719781 April 13, 2004 Kim
6719786 April 13, 2004 Ryan et al.
6719788 April 13, 2004 Cox
6723038 April 20, 2004 Schroeder et al.
6726716 April 27, 2004 Marquez
6726717 April 27, 2004 Alfieri et al.
6730118 May 4, 2004 Spenser et al.
6730121 May 4, 2004 Ortiz et al.
6733525 May 11, 2004 Yang et al.
6749630 June 15, 2004 McCarthy et al.
6752813 June 22, 2004 Goldfarb et al.
6764310 July 20, 2004 Ichihashi et al.
6764510 July 20, 2004 Vidlund et al.
6764514 July 20, 2004 Li et al.
6764518 July 20, 2004 Godin
6767362 July 27, 2004 Schreck
6770083 August 3, 2004 Seguin
6786924 September 7, 2004 Ryan et al.
6786925 September 7, 2004 Schoon et al.
6790231 September 14, 2004 Liddicoat et al.
6797001 September 28, 2004 Mathis et al.
6797002 September 28, 2004 Spence et al.
6802319 October 12, 2004 Stevens et al.
6805710 October 19, 2004 Bolling et al.
6805711 October 19, 2004 Quijano et al.
6821297 November 23, 2004 Snyders
6830585 December 14, 2004 Artof et al.
6830638 December 14, 2004 Boylan et al.
6855126 February 15, 2005 Flinchbaugh
6858039 February 22, 2005 McCarthy
6884250 April 26, 2005 Monassevitch et al.
6884257 April 26, 2005 Cox
6893459 May 17, 2005 Macoviak
6893460 May 17, 2005 Spenser et al.
6908482 June 21, 2005 McCarthy et al.
6918917 July 19, 2005 Nguyen et al.
6926715 August 9, 2005 Hauck et al.
6926730 August 9, 2005 Nguyen et al.
6951571 October 4, 2005 Srivastava
6960217 November 1, 2005 Bolduc
6964684 November 15, 2005 Ortiz et al.
6964686 November 15, 2005 Gordon
6974476 December 13, 2005 McGuckin et al.
6976995 December 20, 2005 Mathis et al.
6986775 January 17, 2006 Morales et al.
6989028 January 24, 2006 Lashinski et al.
6997951 February 14, 2006 Solem et al.
7004176 February 28, 2006 Lau
7011669 March 14, 2006 Kimblad
7011681 March 14, 2006 Vesely
7011682 March 14, 2006 Lashinski et al.
7018406 March 28, 2006 Seguin et al.
7037334 May 2, 2006 Hlavka et al.
7041132 May 9, 2006 Quijano et al.
7074236 July 11, 2006 Rabkin et al.
7077850 July 18, 2006 Kortenbach
7077861 July 18, 2006 Spence
7077862 July 18, 2006 Vidlund et al.
7087064 August 8, 2006 Hyde
7101395 September 5, 2006 Tremulis et al.
7101396 September 5, 2006 Artof et al.
7112207 September 26, 2006 Allen et al.
7118595 October 10, 2006 Ryan et al.
7125421 October 24, 2006 Tremulis et al.
7137184 November 21, 2006 Schreck
7150737 December 19, 2006 Purdy et al.
7159593 January 9, 2007 McCarthy et al.
7166127 January 23, 2007 Spence et al.
7169187 January 30, 2007 Datta et al.
7172625 February 6, 2007 Shu et al.
7175656 February 13, 2007 Khairkhahan
7175660 February 13, 2007 Cartledge et al.
7186262 March 6, 2007 Saadat
7186264 March 6, 2007 Liddicoat et al.
7189199 March 13, 2007 McCarthy et al.
7192443 March 20, 2007 Solem et al.
7198646 April 3, 2007 Figulla et al.
7201772 April 10, 2007 Schwammenthal
7220277 May 22, 2007 Arru et al.
7226467 June 5, 2007 Lucatero et al.
7226477 June 5, 2007 Cox
7226647 June 5, 2007 Kasperchik et al.
7229452 June 12, 2007 Kayan
7238191 July 3, 2007 Bachmann
7261686 August 28, 2007 Couvillon, Jr.
7288097 October 30, 2007 Seguin
7288111 October 30, 2007 Holloway et al.
7294148 November 13, 2007 McCarthy
7297150 November 20, 2007 Cartledge et al.
7311728 December 25, 2007 Solem et al.
7311729 December 25, 2007 Mathis et al.
7314485 January 1, 2008 Mathis
7316710 January 8, 2008 Cheng et al.
7316716 January 8, 2008 Egan
7329279 February 12, 2008 Haug et al.
7329280 February 12, 2008 Bolling et al.
7335213 February 26, 2008 Hyde et al.
7351256 April 1, 2008 Hojeibane et al.
7361190 April 22, 2008 Shoulian et al.
7364588 April 29, 2008 Mathis et al.
7374571 May 20, 2008 Pease et al.
7374573 May 20, 2008 Gabbay
7377938 May 27, 2008 Sarac et al.
7377941 May 27, 2008 Rhee et al.
7381218 June 3, 2008 Schreck
7381219 June 3, 2008 Salahieh et al.
7390329 June 24, 2008 Westra et al.
7404824 July 29, 2008 Webler et al.
7422603 September 9, 2008 Lane
7429269 September 30, 2008 Schwammenthal
7431692 October 7, 2008 Zollinger et al.
7442204 October 28, 2008 Schwammenthal
7442207 October 28, 2008 Rafiee
7445630 November 4, 2008 Lashinski et al.
7452376 November 18, 2008 Lim et al.
7455677 November 25, 2008 Vargas et al.
7455688 November 25, 2008 Furst et al.
7455690 November 25, 2008 Cartledge et al.
7462162 December 9, 2008 Phan et al.
7481838 January 27, 2009 Carpentier et al.
7485142 February 3, 2009 Milo
7500989 March 10, 2009 Solem et al.
7507252 March 24, 2009 Lashinski et al.
7510575 March 31, 2009 Spenser et al.
7510577 March 31, 2009 Moaddeb et al.
7513909 April 7, 2009 Lane et al.
7524331 April 28, 2009 Birdsall
7527646 May 5, 2009 Rahdert et al.
7527647 May 5, 2009 Spence
7530995 May 12, 2009 Quijano et al.
7549983 June 23, 2009 Roue et al.
7556632 July 7, 2009 Zadno
7556646 July 7, 2009 Yang et al.
7559936 July 14, 2009 Levine
7562660 July 21, 2009 Saadat
7563267 July 21, 2009 Goldfarb et al.
7563273 July 21, 2009 Goldfarb et al.
7569062 August 4, 2009 Kuehn et al.
7582111 September 1, 2009 Krolik et al.
7585321 September 8, 2009 Cribier
7588582 September 15, 2009 Starksen et al.
7591826 September 22, 2009 Alferness et al.
7597711 October 6, 2009 Drews et al.
7604646 October 20, 2009 Goldfarb et al.
7608091 October 27, 2009 Goldfarb et al.
7608103 October 27, 2009 McCarthy
7611534 November 3, 2009 Kapadia et al.
7618449 November 17, 2009 Tremulis et al.
7621948 November 24, 2009 Hermann et al.
7625403 December 1, 2009 Krivoruchko
7632302 December 15, 2009 Vreeman et al.
7632303 December 15, 2009 Stalker et al.
7635329 December 22, 2009 Goldfarb et al.
7635386 December 22, 2009 Gammie
7648528 January 19, 2010 Styrc
7655015 February 2, 2010 Goldfarb et al.
7666204 February 23, 2010 Thornton et al.
7682319 March 23, 2010 Martin
7682369 March 23, 2010 Seguin
7682380 March 23, 2010 Thornton et al.
7686822 March 30, 2010 Shayani
7699892 April 20, 2010 Rafiee et al.
7704269 April 27, 2010 St. Goar et al.
7704277 April 27, 2010 Zakay et al.
7708775 May 4, 2010 Rowe et al.
7717952 May 18, 2010 Case et al.
7717955 May 18, 2010 Lane et al.
7722666 May 25, 2010 Lafontaine
7731741 June 8, 2010 Eidenschink
7731742 June 8, 2010 Schlick et al.
7736388 June 15, 2010 Goldfarb et al.
7748389 July 6, 2010 Salahieh et al.
7753922 July 13, 2010 Starksen
7753924 July 13, 2010 Starksen et al.
7753949 July 13, 2010 Lamphere et al.
7758595 July 20, 2010 Allen et al.
7758632 July 20, 2010 Hojeibane et al.
7758640 July 20, 2010 Vesely
7771467 August 10, 2010 Svensson
7771469 August 10, 2010 Liddicoat
7776080 August 17, 2010 Bei et al.
7776083 August 17, 2010 Vesely
7780726 August 24, 2010 Seguin
7785341 August 31, 2010 Forster et al.
7799069 September 21, 2010 Bailey et al.
7803181 September 28, 2010 Furst et al.
7811296 October 12, 2010 Goldfarb et al.
7811316 October 12, 2010 Kalmann et al.
7824442 November 2, 2010 Salahieh et al.
7837645 November 23, 2010 Bessler et al.
7837727 November 23, 2010 Goetz et al.
7842081 November 30, 2010 Yadin
7850725 December 14, 2010 Vardi et al.
7871368 January 18, 2011 Zollinger et al.
7871432 January 18, 2011 Bergin
7871433 January 18, 2011 Lattouf
7871436 January 18, 2011 Ryan et al.
7887583 February 15, 2011 Macoviak
7892281 February 22, 2011 Seguin et al.
7896915 March 1, 2011 Guyenot et al.
7914544 March 29, 2011 Nguyen et al.
7914569 March 29, 2011 Nguyen et al.
7927370 April 19, 2011 Webler et al.
7927371 April 19, 2011 Navia et al.
7942927 May 17, 2011 Kaye et al.
7947072 May 24, 2011 Yang et al.
7947075 May 24, 2011 Goetz et al.
7951195 May 31, 2011 Antonsson et al.
7955375 June 7, 2011 Agnew
7955377 June 7, 2011 Melsheimer
7955384 June 7, 2011 Rafiee et al.
7959666 June 14, 2011 Salahieh et al.
7959672 June 14, 2011 Salahieh et al.
7967833 June 28, 2011 Sterman et al.
7967857 June 28, 2011 Lane
7981151 July 19, 2011 Rowe
7981153 July 19, 2011 Fogarty et al.
7988725 August 2, 2011 Gross et al.
7992567 August 9, 2011 Hirotsuka et al.
7993368 August 9, 2011 Gambale et al.
7993393 August 9, 2011 Carpentier et al.
7993397 August 9, 2011 Lashinski
8002825 August 23, 2011 Letac et al.
8002826 August 23, 2011 Seguin
8012201 September 6, 2011 Lashinski et al.
8016877 September 13, 2011 Seguin et al.
8016882 September 13, 2011 Macoviak
8021420 September 20, 2011 Dolan
8021421 September 20, 2011 Fogarty et al.
8025695 September 27, 2011 Fogarty et al.
8029518 October 4, 2011 Goldfarb et al.
8029557 October 4, 2011 Sobrino-Serrano et al.
8029564 October 4, 2011 Johnson et al.
8034103 October 11, 2011 Burriesci
8034104 October 11, 2011 Carpentier et al.
8038720 October 18, 2011 Wallace et al.
8043360 October 25, 2011 McNamara et al.
8048138 November 1, 2011 Sulivan et al.
8048140 November 1, 2011 Purdy
8048153 November 1, 2011 Salahieh et al.
8052592 November 8, 2011 Goldfarb et al.
8052741 November 8, 2011 Bruszewski et al.
8052749 November 8, 2011 Salahieh et al.
8057493 November 15, 2011 Goldfarb et al.
8057532 November 15, 2011 Hoffman
8057540 November 15, 2011 Letac et al.
8062355 November 22, 2011 Figulla et al.
8062359 November 22, 2011 Marquez et al.
8070708 December 6, 2011 Rottenberg et al.
8070800 December 6, 2011 Lock et al.
8070802 December 6, 2011 Lamphere et al.
8070804 December 6, 2011 Hyde
8070805 December 6, 2011 Vidlund
8075611 December 13, 2011 Milwee et al.
8075616 December 13, 2011 Solem
8080054 December 20, 2011 Rowe
8083793 December 27, 2011 Lane et al.
D652927 January 24, 2012 Braido et al.
D653341 January 31, 2012 Braido et al.
8092518 January 10, 2012 Schreck
8092520 January 10, 2012 Quadri
8092521 January 10, 2012 Figulla et al.
8100964 January 24, 2012 Spence
8105377 January 31, 2012 Liddicoat
8109996 February 7, 2012 Stacchino et al.
8118866 February 21, 2012 Herrmann et al.
8123800 February 28, 2012 McCarthy
8123801 February 28, 2012 Milo
8323334 December 4, 2012 Deem et al.
8133270 March 13, 2012 Kheradvar et al.
8136218 March 20, 2012 Millwee et al.
8137398 March 20, 2012 Tuval et al.
8142492 March 27, 2012 Forster et al.
8142493 March 27, 2012 Spence et al.
8142494 March 27, 2012 Rahdert et al.
8142495 March 27, 2012 Hasenkam et al.
8142496 March 27, 2012 Berreklouw
8142497 March 27, 2012 Friedman
8147504 April 3, 2012 Ino et al.
8147542 April 3, 2012 Maisano et al.
8152844 April 10, 2012 Rao
8157852 April 17, 2012 Bloom et al.
8157853 April 17, 2012 Laske et al.
8157860 April 17, 2012 McNamara et al.
8163008 April 24, 2012 Wilson et al.
8163013 April 24, 2012 Machold et al.
8163014 April 24, 2012 Lane et al.
D660433 May 22, 2012 Braido et al.
D660967 May 29, 2012 Braido et al.
8167894 May 1, 2012 Miles et al.
8167932 May 1, 2012 Bourang et al.
8167935 May 1, 2012 McGuckin, Jr. et al.
8172896 May 8, 2012 McNamara et al.
8172898 May 8, 2012 Alferness et al.
8177836 May 15, 2012 Lee et al.
8182528 May 22, 2012 Salahieh et al.
8187299 May 29, 2012 Goldfarb et al.
8187324 May 29, 2012 Webler et al.
8202315 June 19, 2012 Hlavka et al.
8206439 June 26, 2012 Gomez-Duran
8211169 July 3, 2012 Lane et al.
8216256 July 10, 2012 Raschdorf, Jr. et al.
8216301 July 10, 2012 Bonhoeffer et al.
8221492 July 17, 2012 Case et al.
8221493 July 17, 2012 Boyle et al.
8226710 July 24, 2012 Nguyen et al.
8226711 July 24, 2012 Mortier et al.
8231670 July 31, 2012 Salahieh et al.
8231671 July 31, 2012 Kim
8236045 August 7, 2012 Benichou et al.
8236049 August 7, 2012 Rowe et al.
8241351 August 14, 2012 Cabiri
8252042 August 28, 2012 McNamara et al.
8252050 August 28, 2012 Maisano et al.
8252051 August 28, 2012 Chau et al.
8252052 August 28, 2012 Salahieh et al.
8257390 September 4, 2012 Carley et al.
8262725 September 11, 2012 Subramanian
8267988 September 18, 2012 Hamer et al.
8277501 October 2, 2012 Chalekian et al.
8277502 October 2, 2012 Miller et al.
8287584 October 16, 2012 Salahieh et al.
8287591 October 16, 2012 Keidar et al.
8298280 October 30, 2012 Yadin et al.
8303608 November 6, 2012 Goldfarb et al.
8303653 November 6, 2012 Bonhoeffer et al.
8308798 November 13, 2012 Pintor et al.
8317853 November 27, 2012 Agnew
8317855 November 27, 2012 Gregorich et al.
8323335 December 4, 2012 Rowe et al.
8328868 December 11, 2012 Paul et al.
8333777 December 18, 2012 Schaller et al.
8337541 December 25, 2012 Quadri et al.
8343173 January 1, 2013 Starksen et al.
8343174 January 1, 2013 Goldfarb et al.
8343213 January 1, 2013 Salahieh et al.
8348999 January 8, 2013 Kheradvar et al.
8349002 January 8, 2013 Milo
8353956 January 15, 2013 Miller et al.
8357195 January 22, 2013 Kuehn
8361144 January 29, 2013 Fish et al.
8366767 February 5, 2013 Zhang
8372140 February 12, 2013 Hoffman et al.
8377119 February 19, 2013 Drews et al.
8382829 February 26, 2013 Call et al.
8388680 March 5, 2013 Starksen et al.
8393517 March 12, 2013 Milo
8398708 March 19, 2013 Meiri et al.
8403981 March 26, 2013 Forster et al.
8403983 March 26, 2013 Quadri et al.
8408214 April 2, 2013 Spenser
8414644 April 9, 2013 Quadri et al.
8425593 April 23, 2013 Braido et al.
8430926 April 30, 2013 Kirson
8430934 April 30, 2013 Das
8444689 May 21, 2013 Zhang
8449599 May 28, 2013 Chau et al.
8449625 May 28, 2013 Campbell et al.
8454686 June 4, 2013 Alkhatib
8460365 June 11, 2013 Haverkost et al.
8460370 June 11, 2013 Zakay et al.
8460371 June 11, 2013 Hlavka et al.
8474460 July 2, 2013 Barrett et al.
8475491 July 2, 2013 Milo
8480732 July 9, 2013 Subramanian
8500800 August 6, 2013 Maisano et al.
8500821 August 6, 2013 Sobrino-Serrano et al.
8512400 August 20, 2013 Tran et al.
8518107 August 27, 2013 Tsukashima et al.
8523881 September 3, 2013 Cabiri et al.
8523940 September 3, 2013 Richardson et al.
8529431 September 10, 2013 Baker et al.
8539662 September 24, 2013 Stacchino et al.
8540767 September 24, 2013 Zhang
8545544 October 1, 2013 Spenser et al.
8545553 October 1, 2013 Zipory et al.
8551160 October 8, 2013 Figulla et al.
8551161 October 8, 2013 Dolan
8562672 October 22, 2013 Bonhoeffer et al.
8568475 October 29, 2013 Nguyen et al.
8579964 November 12, 2013 Lane et al.
8579965 November 12, 2013 Bonhoeffer et al.
8585755 November 19, 2013 Chau et al.
8585756 November 19, 2013 Bonhoeffer et al.
8591460 November 26, 2013 Wilson et al.
8591570 November 26, 2013 Revuelta et al.
8591576 November 26, 2013 Hasenkam et al.
8608797 December 17, 2013 Gross et al.
8623075 January 7, 2014 Murray et al.
8623080 January 7, 2014 Fogarty et al.
8628569 January 14, 2014 Benichou et al.
8628570 January 14, 2014 Seguin
8628571 January 14, 2014 Hacohen et al.
8641727 February 4, 2014 Starksen et al.
8652202 February 18, 2014 Alon et al.
8652203 February 18, 2014 Quadri et al.
8652204 February 18, 2014 Quill et al.
8657872 February 25, 2014 Seguin
8663322 March 4, 2014 Keranen
8673020 March 18, 2014 Sobrino-Serrano et al.
8679174 March 25, 2014 Ottma et al.
8685086 April 1, 2014 Navia et al.
8690939 April 8, 2014 Miller et al.
8696742 April 15, 2014 Pintor et al.
8715342 May 6, 2014 Zipory et al.
8728097 May 20, 2014 Sugimoto et al.
8728155 May 20, 2014 Montorfano et al.
8734467 May 27, 2014 Miller et al.
8734507 May 27, 2014 Keranen
8740920 June 3, 2014 Goldfarb et al.
8747460 June 10, 2014 Tuval et al.
8771345 July 8, 2014 Tuval et al.
8778021 July 15, 2014 Cartledge
8784472 July 22, 2014 Eidenschink
8784479 July 22, 2014 Antonsson et al.
8784481 July 22, 2014 Alkhatib et al.
8790367 July 29, 2014 Nguyen et al.
8790394 July 29, 2014 Miller et al.
8795298 August 5, 2014 Hernlund et al.
8795355 August 5, 2014 Alkhatib
8795356 August 5, 2014 Quadri et al.
8795357 August 5, 2014 Yohanan et al.
8801776 August 12, 2014 House et al.
8808366 August 19, 2014 Braido et al.
8808368 August 19, 2014 Maisano et al.
8808371 August 19, 2014 Cartledge
8840663 September 23, 2014 Salahieh et al.
8840664 September 23, 2014 Karapetian et al.
8845717 September 30, 2014 Khairkhahan et al.
8845722 September 30, 2014 Gabbay
8845723 September 30, 2014 Spence et al.
8852261 October 7, 2014 White
8852272 October 7, 2014 Gross et al.
8858623 October 14, 2014 Miller et al.
8864822 October 21, 2014 Spence et al.
8870948 October 28, 2014 Erzberger et al.
8870949 October 28, 2014 Rowe
8870950 October 28, 2014 Hacohen
8876800 November 4, 2014 Behan
8888843 November 18, 2014 Khairkhahan et al.
8894702 November 25, 2014 Quadri et al.
8900294 December 2, 2014 Paniagua et al.
8900295 December 2, 2014 Migliazza et al.
8906083 December 9, 2014 Obermiller et al.
8911455 December 16, 2014 Quadri et al.
8911461 December 16, 2014 Traynor et al.
8911489 December 16, 2014 Ben-Muvhar
8911493 December 16, 2014 Rowe et al.
8911494 December 16, 2014 Hammer et al.
8926695 January 6, 2015 Gross et al.
8926696 January 6, 2015 Cabiri et al.
8926697 January 6, 2015 Gross et al.
8932343 January 13, 2015 Alkhatib et al.
8932348 January 13, 2015 Solem et al.
8940042 January 27, 2015 Miller et al.
8940044 January 27, 2015 Hammer et al.
8945177 February 3, 2015 Dell et al.
8945211 February 3, 2015 Sugimoto
8951285 February 10, 2015 Sugimoto et al.
8951286 February 10, 2015 Sugimoto et al.
8961595 February 24, 2015 Alkhatib
8979922 March 17, 2015 Jayasinghe et al.
8986370 March 24, 2015 Annest
8986373 March 24, 2015 Chau et al.
8986375 March 24, 2015 Garde et al.
8992599 March 31, 2015 Thubrikar et al.
8992604 March 31, 2015 Gross et al.
8992608 March 31, 2015 Haug et al.
8998982 April 7, 2015 Richter et al.
9005273 April 14, 2015 Salahieh et al.
9011468 April 21, 2015 Ketai et al.
9011520 April 21, 2015 Miller et al.
9011527 April 21, 2015 Li et al.
9011530 April 21, 2015 Reich et al.
9017399 April 28, 2015 Gross et al.
D730520 May 26, 2015 Braido et al.
D730521 May 26, 2015 Braido et al.
9023100 May 5, 2015 Quadri et al.
9034032 May 19, 2015 McLean et al.
9034033 May 19, 2015 McLean et al.
9039757 May 26, 2015 McLean et al.
D732666 June 23, 2015 Nguyen et al.
9050188 June 9, 2015 Schweich et al.
9060858 June 23, 2015 Thornton et al.
9072603 July 7, 2015 Tuval et al.
9084676 July 21, 2015 Chau et al.
9095434 August 4, 2015 Rowe
9119719 September 1, 2015 Zipory et al.
9125632 September 8, 2015 Loulmet et al.
9125738 September 8, 2015 Figulla et al.
9125740 September 8, 2015 Morriss et al.
9132006 September 15, 2015 Spenser et al.
9132009 September 15, 2015 Hacohen et al.
9138312 September 22, 2015 Tuval et al.
9155619 October 13, 2015 Liu et al.
9173646 November 3, 2015 Fabro
9173659 November 3, 2015 Bodewadt et al.
9173738 November 3, 2015 Murray et al.
9180005 November 10, 2015 Lashinski et al.
9192472 November 24, 2015 Gross et al.
9220594 December 29, 2015 Braido et al.
9226820 January 5, 2016 Braido et al.
9226825 January 5, 2016 Starksen et al.
9226839 January 5, 2016 Kariniemi et al.
9232995 January 12, 2016 Kovalsky et al.
9241790 January 26, 2016 Lane et al.
9241791 January 26, 2016 Braido et al.
9241792 January 26, 2016 Benichou et al.
9241794 January 26, 2016 Braido et al.
9248014 February 2, 2016 Lane et al.
9265608 February 23, 2016 Miller et al.
9277994 March 8, 2016 Miller et al.
9289290 March 22, 2016 Alkhatib et al.
9289291 March 22, 2016 Gorman et al.
9295550 March 29, 2016 Nguyen et al.
9295551 March 29, 2016 Straubinger et al.
9295552 March 29, 2016 McLean et al.
9301836 April 5, 2016 Buchbinder et al.
9308087 April 12, 2016 Lane et al.
9320591 April 26, 2016 Bolduc
D755384 May 3, 2016 Pesce et al.
9326852 May 3, 2016 Spenser
9326876 May 3, 2016 Acosta et al.
9345573 May 24, 2016 Nyuli et al.
9351830 May 31, 2016 Gross et al.
9387078 July 12, 2016 Gross et al.
9393110 July 19, 2016 Levi et al.
9421098 August 23, 2016 Gifford et al.
9427303 August 30, 2016 Liddy et al.
9427316 August 30, 2016 Schweich, Jr. et al.
9439757 September 13, 2016 Wallace et al.
9463102 October 11, 2016 Kelly
9474599 October 25, 2016 Keränen
9474638 October 25, 2016 Robinson et al.
9480559 November 1, 2016 Vidlund et al.
9492273 November 15, 2016 Wallace et al.
9498314 November 22, 2016 Behan
9498332 November 22, 2016 Hacohen et al.
9510947 December 6, 2016 Straubinger et al.
9532870 January 3, 2017 Cooper et al.
9554897 January 31, 2017 Lane et al.
9554899 January 31, 2017 Granada et al.
9561103 February 7, 2017 Granada et al.
9566152 February 14, 2017 Schweich et al.
9597182 March 21, 2017 Straubinger et al.
9629716 April 25, 2017 Seguin
9662203 May 30, 2017 Sheahan et al.
9681952 June 20, 2017 Hacohen et al.
9717591 August 1, 2017 Chau et al.
9743932 August 29, 2017 Amplatz et al.
9763657 September 19, 2017 Hacohen et al.
9763817 September 19, 2017 Roeder
9770256 September 26, 2017 Cohen et al.
D800908 October 24, 2017 Hariton et al.
9788941 October 17, 2017 Hacohen
9895226 February 20, 2018 Harari et al.
9974651 May 22, 2018 Hariton et al.
9987132 June 5, 2018 Hariton et al.
9993360 June 12, 2018 Shalev et al.
10010414 July 3, 2018 Cooper et al.
10045845 August 14, 2018 Hacohen et al.
10076415 September 18, 2018 Metchik et al.
10098732 October 16, 2018 Hariton et al.
10105222 October 23, 2018 Metchik et al.
10111751 October 30, 2018 Metchik et al.
10123873 November 13, 2018 Metchik et al.
10130475 November 20, 2018 Metchik et al.
10136993 November 27, 2018 Metchik et al.
10143552 December 4, 2018 Wallace et al.
10149761 December 11, 2018 Granada et al.
10154903 December 18, 2018 Albitov et al.
10154906 December 18, 2018 Granada et al.
10159570 December 25, 2018 Metchik et al.
10182908 January 22, 2019 Tubishevitz et al.
10206668 February 19, 2019 Mcgoldrick et al.
10226341 March 12, 2019 Gross et al.
10231831 March 19, 2019 Hacohen
10231837 March 19, 2019 Metchik et al.
10238493 March 26, 2019 Metchik et al.
10245143 April 2, 2019 Gross et al.
10245144 April 2, 2019 Metchik et al.
10258471 April 16, 2019 Lutter et al.
10292816 May 21, 2019 Raanani et al.
10299927 May 28, 2019 McLean et al.
10321995 June 18, 2019 Christianson et al.
10322020 June 18, 2019 Lam et al.
10327895 June 25, 2019 Lozonschi et al.
10335278 July 2, 2019 McLean et al.
10376361 August 13, 2019 Gross et al.
10390952 August 27, 2019 Hariton et al.
10426614 October 1, 2019 Hariton et al.
10449047 October 22, 2019 Hariton et al.
10456256 October 29, 2019 Braido et al.
10492908 December 3, 2019 Hammer et al.
10507108 December 17, 2019 Delgado et al.
10507109 December 17, 2019 Metchik et al.
10512456 December 24, 2019 Hacohen et al.
10517719 December 31, 2019 Miller et al.
10524792 January 7, 2020 Hernandez et al.
10524910 January 7, 2020 Hammer et al.
10531866 January 14, 2020 Hariton et al.
10531872 January 14, 2020 Hacohen et al.
10537426 January 21, 2020 Iamberger et al.
10548726 February 4, 2020 Hacohen et al.
10548731 February 4, 2020 Lashinski et al.
10575948 March 3, 2020 Iamberger et al.
10595992 March 24, 2020 Chambers
10595997 March 24, 2020 Metchik et al.
10610358 April 7, 2020 Vidlund et al.
10610359 April 7, 2020 Hacohen
10631871 April 28, 2020 Goldfarb et al.
10631982 April 28, 2020 Hammer et al.
10646342 May 12, 2020 Marr et al.
10660751 May 26, 2020 Hacohen
10667908 June 2, 2020 Hariton et al.
10667912 June 2, 2020 Dixon et al.
10682227 June 16, 2020 Hariton et al.
10695177 June 30, 2020 Hariton et al.
10702385 July 7, 2020 Hacohen et al.
10736742 August 11, 2020 Hariton et al.
10758342 September 1, 2020 Chau et al.
10779939 September 22, 2020 Hariton et al.
10813760 October 27, 2020 Metchik et al.
10820998 November 3, 2020 Marr et al.
10842627 November 24, 2020 Delgado et al.
10856972 December 8, 2020 Hariton et al.
10856975 December 8, 2020 Hariton et al.
10856978 December 8, 2020 Straubinger et al.
10874514 December 29, 2020 Dixon et al.
10888422 January 12, 2021 Hariton et al.
10888425 January 12, 2021 Delgado et al.
10888644 January 12, 2021 Ratz et al.
10905552 February 2, 2021 Dixon et al.
10905554 February 2, 2021 Cao
10918481 February 16, 2021 Hariton et al.
10918483 February 16, 2021 Metchik et al.
10925732 February 23, 2021 Delgado et al.
10945843 March 16, 2021 Delgado et al.
10945844 March 16, 2021 McCann et al.
10952850 March 23, 2021 Hariton et al.
10959846 March 30, 2021 Marr et al.
10993809 May 4, 2021 McCann et al.
11065114 July 20, 2021 Raanani et al.
11083582 August 10, 2021 McCann et al.
11147672 October 19, 2021 McCann et al.
11179240 November 23, 2021 Delgado et al.
11291545 April 5, 2022 Hacohen
11291546 April 5, 2022 Gross et al.
11291547 April 5, 2022 Gross et al.
11304806 April 19, 2022 Hariton et al.
11389297 July 19, 2022 Franklin et al.
20010002445 May 31, 2001 Vesely
20010005787 June 28, 2001 Oz et al.
20010021872 September 13, 2001 Bailey et al.
20010021874 September 13, 2001 Carpentier et al.
20010044656 November 22, 2001 Williamson et al.
20010056295 December 27, 2001 Solem
20020013571 January 31, 2002 Goldfarb et al.
20020022862 February 21, 2002 Grafton et al.
20020029080 March 7, 2002 Mortier et al.
20020032481 March 14, 2002 Gabbay
20020042621 April 11, 2002 Liddicoat et al.
20020082525 June 27, 2002 Oslund et al.
20020087048 July 4, 2002 Brock et al.
20020099436 July 25, 2002 Thornton et al.
20020103532 August 1, 2002 Langberg et al.
20020151916 October 17, 2002 Muramatsu et al.
20020151961 October 17, 2002 Lashinski et al.
20020151970 October 17, 2002 Garrison et al.
20020169358 November 14, 2002 Mortier et al.
20020173841 November 21, 2002 Ortiz et al.
20020177894 November 28, 2002 Acosta et al.
20020177904 November 28, 2002 Huxel et al.
20020198586 December 26, 2002 Inoue
20030009236 January 9, 2003 Godin
20030018358 January 23, 2003 Saadat
20030036791 February 20, 2003 Philipp et al.
20030050693 March 13, 2003 Quijano et al.
20030050694 March 13, 2003 Yang et al.
20030060846 March 27, 2003 Egnelov et al.
20030060875 March 27, 2003 Wittens
20030069635 April 10, 2003 Cartledge
20030074052 April 17, 2003 Besselink
20030078465 April 24, 2003 Pai et al.
20030078653 April 24, 2003 Vesely et al.
20030083742 May 1, 2003 Spence et al.
20030100943 May 29, 2003 Bolduc
20030105519 June 5, 2003 Fasol et al.
20030114901 June 19, 2003 Loeb et al.
20030130731 July 10, 2003 Vidlund et al.
20030158578 August 21, 2003 Pantages et al.
20030167062 September 4, 2003 Gambale et al.
20030171760 September 11, 2003 Gambale
20030191528 October 9, 2003 Quijano et al.
20030199974 October 23, 2003 Lee et al.
20030204195 October 30, 2003 Keane et al.
20030229350 December 11, 2003 Kay
20030229395 December 11, 2003 Cox
20030233142 December 18, 2003 Morales et al.
20040010272 January 15, 2004 Manetakis et al.
20040019377 January 29, 2004 Taylor et al.
20040024451 February 5, 2004 Johnson et al.
20040030382 February 12, 2004 St. Goar et al.
20040039414 February 26, 2004 Carley et al.
20040039436 February 26, 2004 Spenser et al.
20040039442 February 26, 2004 St. Goar et al.
20040049207 March 11, 2004 Goldfarb et al.
20040059413 March 25, 2004 Argento
20040092962 May 13, 2004 Thornton et al.
20040093060 May 13, 2004 Seguin et al.
20040122448 June 24, 2004 Levine
20040122503 June 24, 2004 Campbell et al.
20040122514 June 24, 2004 Fogarty et al.
20040127982 July 1, 2004 Machold et al.
20040127983 July 1, 2004 Mortier et al.
20040133220 July 8, 2004 Lashinski et al.
20040133267 July 8, 2004 Lane
20040133274 July 8, 2004 Webler et al.
20040133374 July 8, 2004 Kattan
20040138744 July 15, 2004 Lashinski et al.
20040138745 July 15, 2004 Macoviak et al.
20040143315 July 22, 2004 Bruun et al.
20040148019 July 29, 2004 Vidlund et al.
20040148020 July 29, 2004 Vidlund et al.
20040148021 July 29, 2004 Cartledge et al.
20040153146 August 5, 2004 Lashinski et al.
20040172046 September 2, 2004 Hlavka et al.
20040176788 September 9, 2004 Opolski
20040176839 September 9, 2004 Huynh et al.
20040181287 September 16, 2004 Gellman
20040186558 September 23, 2004 Pavenik et al.
20040186565 September 23, 2004 Schreck
20040186566 September 23, 2004 Hindrichs et al.
20040210244 October 21, 2004 Vargas et al.
20040210304 October 21, 2004 Seguin et al.
20040220593 November 4, 2004 Greenhalgh
20040225354 November 11, 2004 Allen et al.
20040236354 November 25, 2004 Seguin
20040236419 November 25, 2004 Milo
20040249433 December 9, 2004 Freitag
20040249453 December 9, 2004 Cartledge et al.
20040260317 December 23, 2004 Bloom et al.
20040260389 December 23, 2004 Case et al.
20040260393 December 23, 2004 Rahdert et al.
20040260394 December 23, 2004 Douk et al.
20040267358 December 30, 2004 Reitan
20050004668 January 6, 2005 Aklog et al.
20050010287 January 13, 2005 Macoviak et al.
20050010787 January 13, 2005 Tarbouriech
20050016560 January 27, 2005 Voughlohn
20050021056 January 27, 2005 St. Goar et al.
20050027305 February 3, 2005 Shiu et al.
20050027348 February 3, 2005 Case et al.
20050038494 February 17, 2005 Eidenschink
20050055038 March 10, 2005 Kelleher et al.
20050055086 March 10, 2005 Stobie
20050055087 March 10, 2005 Starksen
20050060030 March 17, 2005 Lashinski et al.
20050065601 March 24, 2005 Lee et al.
20050070999 March 31, 2005 Spence
20050075726 April 7, 2005 Svanidze et al.
20050075727 April 7, 2005 Wheatley
20050075731 April 7, 2005 Artof et al.
20050080430 April 14, 2005 Wright et al.
20050080474 April 14, 2005 Andreas et al.
20050085900 April 21, 2005 Case et al.
20050085903 April 21, 2005 Lau
20050090827 April 28, 2005 Gedebou
20050096740 May 5, 2005 Langberg et al.
20050107871 May 19, 2005 Realyvasquez et al.
20050119734 June 2, 2005 Spence et al.
20050125002 June 9, 2005 Baran et al.
20050125011 June 9, 2005 Spence et al.
20050131533 June 16, 2005 Alfieri et al.
20050137686 June 23, 2005 Salahieh et al.
20050137688 June 23, 2005 Salahieh et al.
20050137689 June 23, 2005 Salahieh et al.
20050137690 June 23, 2005 Salahieh et al.
20050137691 June 23, 2005 Salahieh et al.
20050137692 June 23, 2005 Haug et al.
20050137693 June 23, 2005 Haug et al.
20050137695 June 23, 2005 Salahieh et al.
20050137697 June 23, 2005 Salahieh et al.
20050137699 June 23, 2005 Salahieh et al.
20050143809 June 30, 2005 Salahieh et al.
20050149160 July 7, 2005 McFerran
20050154443 July 14, 2005 Linder et al.
20050159728 July 21, 2005 Armour et al.
20050171601 August 4, 2005 Cosgrove et al.
20050177180 August 11, 2005 Kaganov et al.
20050177228 August 11, 2005 Solem et al.
20050182483 August 18, 2005 Osborne et al.
20050182486 August 18, 2005 Gabbay
20050187613 August 25, 2005 Bolduc et al.
20050192596 September 1, 2005 Jugenheimer et al.
20050197695 September 8, 2005 Stacchino et al.
20050197696 September 8, 2005 Gomez Duran
20050203549 September 15, 2005 Realyvasquez
20050203606 September 15, 2005 VanCamp
20050203618 September 15, 2005 Sharkawy et al.
20050216039 September 29, 2005 Lederman
20050216079 September 29, 2005 MaCoviak
20050222665 October 6, 2005 Aranyi
20050222678 October 6, 2005 Lashinski et al.
20050234508 October 20, 2005 Cummins et al.
20050240200 October 27, 2005 Bergheim
20050251251 November 10, 2005 Cribier
20050256532 November 17, 2005 Nayak et al.
20050256566 November 17, 2005 Gabbay
20050267478 December 1, 2005 Corradi et al.
20050267573 December 1, 2005 Macoviak et al.
20050273138 December 8, 2005 To et al.
20050288776 December 29, 2005 Shaoulian et al.
20050288778 December 29, 2005 Shaoulian et al.
20050288781 December 29, 2005 Moaddeb et al.
20060004439 January 5, 2006 Spenser et al.
20060004442 January 5, 2006 Spenser et al.
20060004443 January 5, 2006 Liddicoat et al.
20060004469 January 5, 2006 Sokel
20060015171 January 19, 2006 Armstrong
20060020275 January 26, 2006 Goldfarb et al.
20060020326 January 26, 2006 Bolduc et al.
20060020327 January 26, 2006 Lashinski et al.
20060020333 January 26, 2006 Lashinski et al.
20060020336 January 26, 2006 Liddicoat
20060025787 February 2, 2006 Morales et al.
20060025855 February 2, 2006 Lashinski et al.
20060025858 February 2, 2006 Alameddine
20060030885 February 9, 2006 Hyde
20060041189 February 23, 2006 Vancaillie
20060041319 February 23, 2006 Taylor et al.
20060052867 March 9, 2006 Revuelta et al.
20060052868 March 9, 2006 Mortier
20060058871 March 16, 2006 Zakay et al.
20060069429 March 30, 2006 Spence et al.
20060074486 April 6, 2006 Liddicoat et al.
20060085012 April 20, 2006 Dolan
20060089627 April 27, 2006 Burnett et al.
20060095009 May 4, 2006 Lampropoulos et al.
20060106423 May 18, 2006 Weisel et al.
20060111773 May 25, 2006 Rittgers et al.
20060116750 June 1, 2006 Herbert et al.
20060116757 June 1, 2006 Lashinski et al.
20060122692 June 8, 2006 Gilad et al.
20060129166 June 15, 2006 Lavelle
20060135964 June 22, 2006 Vesley
20060149280 July 6, 2006 Harvine et al.
20060149368 July 6, 2006 Spence
20060155357 July 13, 2006 Melsheimer
20060161250 July 20, 2006 Shaw
20060161265 July 20, 2006 Levine et al.
20060047297 March 2, 2006 Case
20060178700 August 10, 2006 Quinn
20060178740 August 10, 2006 Stacchino et al.
20060184203 August 17, 2006 Martin et al.
20060184240 August 17, 2006 Jimenez et al.
20060184242 August 17, 2006 Lichtenstein
20060190036 August 24, 2006 Wendel et al.
20060190038 August 24, 2006 Carley et al.
20060195134 August 31, 2006 Crittenden
20060195183 August 31, 2006 Navia et al.
20060195184 August 31, 2006 Lane et al.
20060201519 September 14, 2006 Frazier et al.
20060212111 September 21, 2006 Case et al.
20060216404 September 28, 2006 Seyler et al.
20060229708 October 12, 2006 Powell et al.
20060241622 October 26, 2006 Zergiebel
20060241656 October 26, 2006 Starksen et al.
20060241745 October 26, 2006 Solem
20060241748 October 26, 2006 Lee et al.
20060247680 November 2, 2006 Amplatz et al.
20060247763 November 2, 2006 Slater
20060253191 November 9, 2006 Salahieh et al.
20060259135 November 16, 2006 Navia et al.
20060259136 November 16, 2006 Nguyen et al.
20060259137 November 16, 2006 Artof et al.
20060271166 November 30, 2006 Thill et al.
20060271171 November 30, 2006 McQuinn et al.
20060271175 November 30, 2006 Woolfson
20060282150 December 14, 2006 Olson et al.
20060282161 December 14, 2006 Huyn et al.
20060287661 December 21, 2006 Bolduc et al.
20060287716 December 21, 2006 Banbury et al.
20060287719 December 21, 2006 Rowe et al.
20070001627 January 4, 2007 Lin et al.
20070008018 January 11, 2007 Nagashima et al.
20070016286 January 18, 2007 Herrmann et al.
20070016287 January 18, 2007 Cartledge et al.
20070016288 January 18, 2007 Gurskis et al.
20070021781 January 25, 2007 Jervis et al.
20070027528 February 1, 2007 Agnew
20070027533 February 1, 2007 Douk
20070027536 February 1, 2007 Mihaljevic et al.
20070027549 February 1, 2007 Godin
20070038221 February 15, 2007 Fine et al.
20070038293 February 15, 2007 St. Goar et al.
20070038295 February 15, 2007 Case et al.
20070043435 February 22, 2007 Seguin et al.
20070049942 March 1, 2007 Hindrichs et al.
20070049970 March 1, 2007 Belef et al.
20070051377 March 8, 2007 Douk et al.
20070055206 March 8, 2007 To et al.
20070055340 March 8, 2007 Pryor
20070056346 March 15, 2007 Spenser et al.
20070061010 March 15, 2007 Hauser et al.
20070066863 March 22, 2007 Rafiee et al.
20070078297 April 5, 2007 Rafiee et al.
20070078510 April 5, 2007 Ryan
20070080188 April 12, 2007 Spence et al.
20070083168 April 12, 2007 Whiting et al.
20070106328 May 10, 2007 Wardle et al.
20070112359 May 17, 2007 Kimura et al.
20070112422 May 17, 2007 Dehdashtian
20070112425 May 17, 2007 Schaller et al.
20070118151 May 24, 2007 Davidson
20070118154 May 24, 2007 Crabtree
20070118213 May 24, 2007 Loulmet
20070118215 May 24, 2007 Moaddeb
20070142907 June 21, 2007 Moaddeb et al.
20070162103 July 12, 2007 Case et al.
20070162107 July 12, 2007 Haug et al.
20070162111 July 12, 2007 Fukamachi et al.
20070173932 July 26, 2007 Cali et al.
20070197858 August 23, 2007 Goldfarb et al.
20070198077 August 23, 2007 Cully et al.
20070198082 August 23, 2007 Kapadia et al.
20070198097 August 23, 2007 Zegdi
20070208550 September 6, 2007 Cao et al.
20070213582 September 13, 2007 Zollinger et al.
20070213810 September 13, 2007 Newhauser et al.
20070213813 September 13, 2007 Von Segesser et al.
20070219558 September 20, 2007 Deutsch
20070219630 September 20, 2007 Chu
20070225759 September 27, 2007 Thommen et al.
20070225760 September 27, 2007 Moszner et al.
20070233186 October 4, 2007 Meng
20070233237 October 4, 2007 Krivoruchko
20070233239 October 4, 2007 Navia et al.
20070239208 October 11, 2007 Crawford
20070239272 October 11, 2007 Navia et al.
20070239273 October 11, 2007 Allen
20070244546 October 18, 2007 Francis
20070244555 October 18, 2007 Rafiee et al.
20070244556 October 18, 2007 Rafiee et al.
20070244557 October 18, 2007 Rafiee et al.
20070250160 October 25, 2007 Rafiee
20070255397 November 1, 2007 Ryan et al.
20070255400 November 1, 2007 Parravicini et al.
20070270755 November 22, 2007 Von Oepen et al.
20070270943 November 22, 2007 Solem et al.
20070276437 November 29, 2007 Call et al.
20070282375 December 6, 2007 Hindrichs et al.
20070282429 December 6, 2007 Hauser et al.
20070295172 December 27, 2007 Swartz
20070299424 December 27, 2007 Cumming et al.
20080004688 January 3, 2008 Spenser et al.
20080004697 January 3, 2008 Lichtenstein et al.
20080027483 January 31, 2008 Cartledge et al.
20080027555 January 31, 2008 Hawkins
20080035160 February 14, 2008 Woodson et al.
20080039935 February 14, 2008 Buch
20080051703 February 28, 2008 Thornton et al.
20080058595 March 6, 2008 Snoke et al.
20080065011 March 13, 2008 Marchand et al.
20080065204 March 13, 2008 Mackoviak et al.
20080071361 March 20, 2008 Tuval et al.
20080071363 March 20, 2008 Tuval et al.
20080071366 March 20, 2008 Tuval et al.
20080071369 March 20, 2008 Tuval et al.
20080077235 March 27, 2008 Kirson
20080082083 April 3, 2008 Forde et al.
20080082159 April 3, 2008 Tseng et al.
20080082166 April 3, 2008 Styrc et al.
20080086138 April 10, 2008 Stone et al.
20080086164 April 10, 2008 Rowe et al.
20080086203 April 10, 2008 Roberts
20080086204 April 10, 2008 Rankin
20080091257 April 17, 2008 Andreas et al.
20080091261 April 17, 2008 Long et al.
20080097523 April 24, 2008 Bolduc et al.
20080097595 April 24, 2008 Gabbay
20080132989 June 5, 2008 Snow et al.
20080140003 June 12, 2008 Bei et al.
20080140116 June 12, 2008 Bonutti
20080147182 June 19, 2008 Righini et al.
20080161910 July 3, 2008 Revuelta et al.
20080167705 July 10, 2008 Agnew
20080167714 July 10, 2008 St. Goar et al.
20080188929 August 7, 2008 Schreck
20080195126 August 14, 2008 Solem
20080195200 August 14, 2008 Vidlund et al.
20080200980 August 21, 2008 Robin et al.
20080208265 August 28, 2008 Frazier et al.
20080208328 August 28, 2008 Antocci et al.
20080208330 August 28, 2008 Keranen
20080208332 August 28, 2008 Lamphere et al.
20080221672 September 11, 2008 Lamphere et al.
20080234814 September 25, 2008 Salahieh et al.
20080243245 October 2, 2008 Thambar et al.
20080255580 October 16, 2008 Hoffman et al.
20080262609 October 23, 2008 Gross et al.
20080269879 October 30, 2008 Sathe et al.
20080275300 November 6, 2008 Rothe et al.
20080275469 November 6, 2008 Fanton et al.
20080275551 November 6, 2008 Alfieri
20080281411 November 13, 2008 Berreklouw
20080288044 November 20, 2008 Osborne
20080288062 November 20, 2008 Andrieu et al.
20080294234 November 27, 2008 Hartley et al.
20080300629 December 4, 2008 Surti
20090005863 January 1, 2009 Goetz et al.
20090036966 February 5, 2009 O'Connor et al.
20090043153 February 12, 2009 Zollinger et al.
20090043381 February 12, 2009 Macoviak et al.
20090054969 February 26, 2009 Salahieh et al.
20090062866 March 5, 2009 Jackson
20090076586 March 19, 2009 Hauser et al.
20090076600 March 19, 2009 Quinn
20090082844 March 26, 2009 Zacharias et al.
20090088836 April 2, 2009 Bishop et al.
20090088837 April 2, 2009 Gillinov et al.
20090099554 April 16, 2009 Forster et al.
20090099650 April 16, 2009 Bolduc et al.
20090105794 April 23, 2009 Ziarno
20090105816 April 23, 2009 Olsen et al.
20090112159 April 30, 2009 Slattery et al.
20090125098 May 14, 2009 Chuter
20090125102 May 14, 2009 Cartledge
20090149872 June 11, 2009 Gross et al.
20090157175 June 18, 2009 Benichou
20090163934 June 25, 2009 Raschdorf, Jr. et al.
20090177274 July 9, 2009 Scorsin et al.
20090171363 July 2, 2009 Chocron
20090171439 July 2, 2009 Niss1
20090177266 July 9, 2009 Powell et al.
20090177277 July 9, 2009 Milo
20090177278 July 9, 2009 Spence
20090210052 August 20, 2009 Forster et al.
20090222081 September 3, 2009 Linder et al.
20090240320 September 24, 2009 Tuval et al.
20090241656 October 1, 2009 Jacquemin
20090248143 October 1, 2009 Laham
20090248148 October 1, 2009 Shaolian et al.
20090254103 October 8, 2009 Deustch
20090259306 October 15, 2009 Rowe
20090259307 October 15, 2009 Gross et al.
20090264859 October 22, 2009 Mas
20090264994 October 22, 2009 Saadat
20090264995 October 22, 2009 Subramanian
20090276040 November 5, 2009 Rowe et al.
20090281619 November 12, 2009 Le et al.
20090287299 November 19, 2009 Tabor et al.
20090287304 November 19, 2009 Dahlgren et al.
20090299409 December 3, 2009 Coe et al.
20090299449 December 3, 2009 Styrc
20090306768 December 10, 2009 Quardi
20090319037 December 24, 2009 Rowe et al.
20090326648 December 31, 2009 Machold et al.
20100001038 January 7, 2010 Levin et al.
20100010538 January 14, 2010 Juravic et al.
20100022823 January 28, 2010 Goldfarb et al.
20100023117 January 28, 2010 Yoganathan et al.
20100023118 January 28, 2010 Medlock et al.
20100023120 January 28, 2010 Holecek et al.
20100030014 February 4, 2010 Ferrazzi
20100036479 February 11, 2010 Hill et al.
20100036484 February 11, 2010 Hariton et al.
20100042147 February 18, 2010 Janovsky et al.
20100049313 February 25, 2010 Alon et al.
20100063542 March 11, 2010 Van der Burg et al.
20100063550 March 11, 2010 Felix et al.
20100063586 March 11, 2010 Hasenkam et al.
20100069852 March 18, 2010 Kelley
20100076499 March 25, 2010 McNamara et al.
20100076548 March 25, 2010 Konno
20100082094 April 1, 2010 Quadri et al.
20100094248 April 15, 2010 Nguyen et al.
20100100167 April 22, 2010 Bortlein et al.
20100114180 May 6, 2010 Rock
20100114299 May 6, 2010 Ben-Muvhar et al.
20100121349 May 13, 2010 Meier
20100130992 May 27, 2010 Machold et al.
20100131054 May 27, 2010 Tuval et al.
20100137979 June 3, 2010 Tuval et al.
20100152845 June 17, 2010 Bloom et al.
20100160958 June 24, 2010 Clark
20100161036 June 24, 2010 Pintor et al.
20100161041 June 24, 2010 Maisano et al.
20100161042 June 24, 2010 Maisano et al.
20100161043 June 24, 2010 Maisano et al.
20100161047 June 24, 2010 Cabiri
20100168845 July 1, 2010 Wright
20100174358 July 8, 2010 Rabkin et al.
20100174363 July 8, 2010 Castro
20100179574 July 15, 2010 Longoria et al.
20100179643 July 15, 2010 Shalev
20100179648 July 15, 2010 Richter et al.
20100179649 July 15, 2010 Richter et al.
20100185277 July 22, 2010 Braido et al.
20100198347 August 5, 2010 Zakay et al.
20100217382 August 26, 2010 Chau et al.
20100222810 September 2, 2010 DeBeer et al.
20100228285 September 9, 2010 Miles et al.
20100234935 September 16, 2010 Bashiri et al.
20100234940 September 16, 2010 Dolan
20100249908 September 30, 2010 Chau et al.
20100249915 September 30, 2010 Zhang
20100249917 September 30, 2010 Zhang
20100249920 September 30, 2010 Bolling et al.
20100256737 October 7, 2010 Pollock et al.
20100262232 October 14, 2010 Annest
20100262233 October 14, 2010 He
20100280603 November 4, 2010 Maisano et al.
20100280604 November 4, 2010 Zipory et al.
20100280605 November 4, 2010 Hammer et al.
20100280606 November 4, 2010 Naor
20100286628 November 11, 2010 Gross
20100286767 November 11, 2010 Zipory et al.
20100305475 December 2, 2010 Hinchliffe et al.
20100312333 December 9, 2010 Navia et al.
20100324595 December 23, 2010 Linder et al.
20100331971 December 30, 2010 Keränen et al.
20110004210 January 6, 2011 Johnson et al.
20110004227 January 6, 2011 Goldfarb et al.
20110004296 January 6, 2011 Lutter et al.
20110004298 January 6, 2011 Lee et al.
20110004299 January 6, 2011 Navia et al.
20110011917 January 20, 2011 Loulmet
20110015729 January 20, 2011 Jimenez et al.
20110015731 January 20, 2011 Carpentier et al.
20110015739 January 20, 2011 Cheung et al.
20110021985 January 27, 2011 Spargias
20110022165 January 27, 2011 Oba et al.
20110178597 July 21, 2011 Navia et al.
20110026208 February 3, 2011 Otsuro et al.
20110029066 February 3, 2011 Gilad et al.
20110029067 February 3, 2011 Mcguckin, Jr. et al.
20110029072 February 3, 2011 Gabbay
20110035000 February 10, 2011 Nieminen et al.
20110040374 February 17, 2011 Goetz et al.
20110040375 February 17, 2011 Letac et al.
20110046662 February 24, 2011 Moszner et al.
20110054466 March 3, 2011 Rothstein et al.
20110054596 March 3, 2011 Taylor
20110054598 March 3, 2011 Johnson
20110066231 March 17, 2011 Cartledge et al.
20110066233 March 17, 2011 Thornton et al.
20110067770 March 24, 2011 Pederson et al.
20110071626 March 24, 2011 Wright et al.
20110077730 March 31, 2011 Fentster
20110082538 April 7, 2011 Dahlgren et al.
20110087146 April 14, 2011 Ryan et al.
20110087322 April 14, 2011 Letac et al.
20110093002 April 21, 2011 Rucker et al.
20110093063 April 21, 2011 Schreck
20110098525 April 28, 2011 Kermode et al.
20110106245 May 5, 2011 Miller et al.
20110106247 May 5, 2011 Miller et al.
20110112625 May 12, 2011 Ben-Muvhar et al.
20110112632 May 12, 2011 Chau et al.
20110113768 May 19, 2011 Bauer et al.
20110118830 May 19, 2011 Liddicoat et al.
20110118832 May 19, 2011 Punjabi
20110125257 May 26, 2011 Seguin et al.
20110125258 May 26, 2011 Centola
20110137326 June 9, 2011 Bachman
20110137397 June 9, 2011 Chau et al.
20110137409 June 9, 2011 Yang et al.
20110137410 June 9, 2011 Hacohen
20110144703 June 16, 2011 Krause et al.
20110144742 June 16, 2011 Madrid et al.
20110166636 July 7, 2011 Rowe
20110166649 July 7, 2011 Gross et al.
20110172784 July 14, 2011 Richter
20110184510 July 28, 2011 Maisano et al.
20110190877 August 4, 2011 Lane et al.
20110190879 August 4, 2011 Bobo et al.
20110202076 August 18, 2011 Richter
20110202130 August 18, 2011 Cartledge et al.
20110208283 August 25, 2011 Rust
20110208293 August 25, 2011 Tabor
20110208298 August 25, 2011 Tuval et al.
20110213459 September 1, 2011 Garrison et al.
20110213461 September 1, 2011 Seguin et al.
20110218619 September 8, 2011 Benichou et al.
20110218620 September 8, 2011 Meiri et al.
20110224785 September 15, 2011 Hacohen
20110230941 September 22, 2011 Markus
20110230961 September 22, 2011 Langer et al.
20110238088 September 29, 2011 Bodluc et al.
20110238094 September 29, 2011 Thomas et al.
20110238159 September 29, 2011 Guyenot et al.
20110245911 October 6, 2011 Quill et al.
20110245917 October 6, 2011 Savage et al.
20110251675 October 13, 2011 Dwork
20110251676 October 13, 2011 Sweeney et al.
20110251678 October 13, 2011 Eidenschink et al.
20110251679 October 13, 2011 Weimeyer et al.
20110251680 October 13, 2011 Tran et al.
20110251682 October 13, 2011 Murray, III et al.
20110251683 October 13, 2011 Tabor
20110257433 October 20, 2011 Walker
20110257633 October 20, 2011 Cartledge et al.
20110257721 October 20, 2011 Tabor
20110257728 October 20, 2011 Kuehn
20110257729 October 20, 2011 Spenser et al.
20110257736 October 20, 2011 Marquez et al.
20110257737 October 20, 2011 Fogarty et al.
20110264191 October 27, 2011 Rothstein
20110264196 October 27, 2011 Savage et al.
20110264198 October 27, 2011 Murray, III et al.
20110264199 October 27, 2011 Tran et al.
20110264200 October 27, 2011 Tran et al.
20110264201 October 27, 2011 Yeung
20110264202 October 27, 2011 Murray, III et al.
20110264203 October 27, 2011 Dwork et al.
20110264206 October 27, 2011 Tabor
20110264208 October 27, 2011 Duffy
20110270276 November 3, 2011 Rothstein et al.
20110271967 November 10, 2011 Mortier et al.
20110276062 November 10, 2011 Bolduc
20110282361 November 17, 2011 Miller et al.
20110282438 November 17, 2011 Drews et al.
20110282439 November 17, 2011 Thill et al.
20110282440 November 17, 2011 Cao
20110283514 November 24, 2011 Fogarty et al.
20110288435 November 24, 2011 Christy et al.
20110288632 November 24, 2011 White
20110288634 November 24, 2011 Tuval et al.
20110288635 November 24, 2011 Miller et al.
20110295354 December 1, 2011 Bueche et al.
20110295363 December 1, 2011 Girard et al.
20110301498 December 8, 2011 Maenhout et al.
20110301688 December 8, 2011 Dolan
20110301698 December 8, 2011 Miller et al.
20110301701 December 8, 2011 Padala et al.
20110301702 December 8, 2011 Rust et al.
20110306916 December 15, 2011 Nitzan et al.
20110307049 December 15, 2011 Kao
20110313452 December 22, 2011 Carley et al.
20110313515 December 22, 2011 Quadri et al.
20110319989 December 29, 2011 Lane et al.
20110319991 December 29, 2011 Hariton et al.
20120010694 January 12, 2012 Lutter et al.
20120016468 January 19, 2012 Robin et al.
20120022557 January 26, 2012 Cabiri et al.
20120022629 January 26, 2012 Perera et al.
20120022633 January 26, 2012 Olson et al.
20120022637 January 26, 2012 Ben-Movhar et al.
20120022639 January 26, 2012 Hacohen et al.
20120022640 January 26, 2012 Gross et al.
20120022644 January 26, 2012 Reich et al.
20120035703 February 9, 2012 Lutter et al.
20120035712 February 9, 2012 Maisano et al.
20120035713 February 9, 2012 Lutter et al.
20120035722 February 9, 2012 Tuval et al.
20120041547 February 16, 2012 Duffy et al.
20120041551 February 16, 2012 Spenser et al.
20120046738 February 23, 2012 Lau et al.
20120046742 February 23, 2012 Tuval et al.
20120053676 March 1, 2012 Ku et al.
20120053680 March 1, 2012 Bolling et al.
20120053682 March 1, 2012 Kovalsky et al.
20120053688 March 1, 2012 Fogarty et al.
20120059337 March 8, 2012 Eilat
20120059454 March 8, 2012 Millwee et al.
20120059458 March 8, 2012 Buchbinder et al.
20120065464 March 15, 2012 Ellis et al.
20120078237 March 29, 2012 Wang et al.
20120078353 March 29, 2012 Quadri et al.
20120078355 March 29, 2012 Zipory et al.
20120078357 March 29, 2012 Conklin
20120078359 March 29, 2012 Li et al.
20120083832 April 5, 2012 Delaloye et al.
20120083839 April 5, 2012 Letac et al.
20120083879 April 5, 2012 Eberhardt et al.
20120089022 April 12, 2012 House et al.
20120089223 April 12, 2012 Nguyen et al.
20120095552 April 19, 2012 Spence et al.
20120101570 April 26, 2012 Tuval et al.
20120101571 April 26, 2012 Thambar et al.
20120101572 April 26, 2012 Kovalsky et al.
20120109155 May 3, 2012 Robinson et al.
20120123511 May 17, 2012 Brown
20120123529 May 17, 2012 Levi et al.
20120123530 May 17, 2012 Carpentier et al.
20120130473 May 24, 2012 Norris et al.
20120130474 May 24, 2012 Buckley
20120130475 May 24, 2012 Shaw
20120136434 May 31, 2012 Carpentier et al.
20120136436 May 31, 2012 Cabiri et al.
20120143323 June 7, 2012 Hasenkam et al.
20120150218 June 14, 2012 Sandgren et al.
20120150290 June 14, 2012 Gabbay
20120158021 June 21, 2012 Morrill
20120165915 June 28, 2012 Melsheimer et al.
20120165930 June 28, 2012 Gifford, III et al.
20120179086 July 12, 2012 Shank et al.
20120179244 July 12, 2012 Schankereli et al.
20120191182 July 26, 2012 Hauser et al.
20120197292 August 2, 2012 Chin-Chen et al.
20120197388 August 2, 2012 Khairkhahan et al.
20120215303 August 23, 2012 Quadri et al.
20120239142 September 20, 2012 Liu et al.
20120245604 September 27, 2012 Tegzes
20120271198 October 25, 2012 Whittaker et al.
20120277845 November 1, 2012 Bowe
20120283757 November 8, 2012 Miller et al.
20120283824 November 8, 2012 Lutter et al.
20120290062 November 15, 2012 McNamara et al.
20120296349 November 22, 2012 Smith et al.
20120296360 November 22, 2012 Norris et al.
20120296417 November 22, 2012 Hill et al.
20120296418 November 22, 2012 Bonyuet et al.
20120296419 November 22, 2012 Richardson
20120300063 November 29, 2012 Majkrzak et al.
20120123531 May 17, 2012 Tsukashima et al.
20120310328 December 6, 2012 Olson et al.
20120310330 December 6, 2012 Buchbinder et al.
20120323313 December 20, 2012 Seguin
20120323316 December 20, 2012 Chau et al.
20120330408 December 27, 2012 Hillukka et al.
20120330410 December 27, 2012 Hammer et al.
20120330411 December 27, 2012 Gross et al.
20130006347 January 3, 2013 McHugo
20130018450 January 17, 2013 Hunt
20130018458 January 17, 2013 Yohanan et al.
20130023758 January 24, 2013 Fabro
20130030519 January 31, 2013 Tran et al.
20130030522 January 31, 2013 Rowe et al.
20130035759 February 7, 2013 Gross et al.
20130041204 February 14, 2013 Heilman et al.
20130041451 February 14, 2013 Patterson et al.
20130046373 February 21, 2013 Cartledge et al.
20130066341 March 14, 2013 Ketai et al.
20130066342 March 14, 2013 Dell et al.
20130079872 March 28, 2013 Gallagher
20130079873 March 28, 2013 Migliazza et al.
20130085529 April 4, 2013 Housman
20130090724 April 11, 2013 Subramanian et al.
20130096673 April 18, 2013 Hill et al.
20130116776 May 9, 2013 Gross et al.
20130116779 May 9, 2013 Weber
20130116780 May 9, 2013 Miller et al.
20130123896 May 16, 2013 Bloss et al.
20130123900 May 16, 2013 Eblacas et al.
20130123910 May 16, 2013 Cartledge et al.
20130131791 May 23, 2013 Hlavka et al.
20130131792 May 23, 2013 Miller et al.
20130150945 June 13, 2013 Crawford et al.
20130150956 June 13, 2013 Yohanan et al.
20130158647 June 20, 2013 Norris et al.
20130166017 June 27, 2013 Cartledge et al.
20130166022 June 27, 2013 Conklin
20130172978 July 4, 2013 Vidlund et al.
20130172992 July 4, 2013 Gross et al.
20130178930 July 11, 2013 Straubinger et al.
20130190857 July 25, 2013 Mitra et al.
20130190861 July 25, 2013 Chau et al.
20130190863 July 25, 2013 Call et al.
20130190866 July 25, 2013 Zipory et al.
20130197632 August 1, 2013 Kovach et al.
20130204361 August 8, 2013 Adams et al.
20130211501 August 15, 2013 Buckley et al.
20130211508 August 15, 2013 Lane et al.
20130226289 August 29, 2013 Shaolian et al.
20130226290 August 29, 2013 Yellin et al.
20130231735 September 5, 2013 Deem et al.
20130245742 September 19, 2013 Norris
20130253643 September 26, 2013 Rolando et al.
20130261737 October 3, 2013 Costello
20130261738 October 3, 2013 Clague et al.
20130268069 October 10, 2013 Zakai et al.
20130274870 October 17, 2013 Lombardi et al.
20130282059 October 24, 2013 Ketai et al.
20130289711 October 31, 2013 Liddy et al.
20130289718 October 31, 2013 Tsukashima et al.
20130289740 October 31, 2013 Liddy et al.
20130297013 November 7, 2013 Klima et al.
20130304093 November 14, 2013 Serina et al.
20130304197 November 14, 2013 Buchbinder et al.
20130304200 November 14, 2013 McLean et al.
20130310928 November 21, 2013 Morriss et al.
20130325114 December 5, 2013 McLean et al.
20130325118 December 5, 2013 Cartledge
20130331929 December 12, 2013 Mitra et al.
20140000112 January 2, 2014 Braido et al.
20140005767 January 2, 2014 Glazier et al.
20140005778 January 2, 2014 Buchbinder et al.
20140018911 January 16, 2014 Zhou et al.
20140018914 January 16, 2014 Zipory et al.
20140018915 January 16, 2014 Biadillah et al.
20140031928 January 30, 2014 Murphy et al.
20140046430 February 13, 2014 Shaw
20140052237 February 20, 2014 Lane et al.
20140067050 March 6, 2014 Costello et al.
20140067054 March 6, 2014 Chau et al.
20140081376 March 20, 2014 Burkart et al.
20140088368 March 27, 2014 Park
20140094826 April 3, 2014 Sutherland et al.
20140094903 April 3, 2014 Miller et al.
20140094906 April 3, 2014 Spence et al.
20140099726 April 10, 2014 Heller
20140106951 April 17, 2014 Brandon
20140120287 May 1, 2014 Jacoby et al.
20140121749 May 1, 2014 Roeder
20140121763 May 1, 2014 Duffy et al.
20140135799 May 15, 2014 Henderson
20140135894 May 15, 2014 Norris et al.
20140135895 May 15, 2014 Andress et al.
20140142619 May 22, 2014 Serina et al.
20140142681 May 22, 2014 Norris
20140142688 May 22, 2014 Duffy et al.
20140142695 May 22, 2014 Gross et al.
20140148849 May 29, 2014 Serina et al.
20140148891 May 29, 2014 Johnson
20140148898 May 29, 2014 Gross et al.
20140155783 June 5, 2014 Starksen et al.
20140163670 June 12, 2014 Alon et al.
20140163690 June 12, 2014 White
20140172069 June 19, 2014 Roeder et al.
20140172077 June 19, 2014 Bruchman et al.
20140172082 June 19, 2014 Bruchman et al.
20140188108 July 3, 2014 Goodine et al.
20140188140 July 3, 2014 Meier et al.
20140188210 July 3, 2014 Beard et al.
20140188215 July 3, 2014 Hlavka et al.
20140188221 July 3, 2014 Chung et al.
20140194970 July 10, 2014 Chobotov
20140194976 July 10, 2014 Starksen et al.
20140194981 July 10, 2014 Menk et al.
20140194983 July 10, 2014 Kovalsky et al.
20140207231 July 24, 2014 Hacohen et al.
20140214157 July 31, 2014 Börtlein et al.
20140214159 July 31, 2014 Vidlund et al.
20140222136 August 7, 2014 Geist et al.
20140222137 August 7, 2014 Miller et al.
20140222142 August 7, 2014 Kovalsky et al.
20140236287 August 21, 2014 Clague et al.
20140236289 August 21, 2014 Alkhatib
20140243859 August 28, 2014 Robinson
20140243894 August 28, 2014 Groothuis et al.
20140243963 August 28, 2014 Sheps et al.
20140249622 September 4, 2014 Carmi et al.
20140257461 September 11, 2014 Robinson et al.
20140257467 September 11, 2014 Lane et al.
20140257475 September 11, 2014 Gross et al.
20140257476 September 11, 2014 Montorfano et al.
20140275757 September 18, 2014 Goodwin et al.
20140276648 September 18, 2014 Hammer et al.
20140277358 September 18, 2014 Slazas
20140277409 September 18, 2014 Börtlein et al.
20140277411 September 18, 2014 Börtlein et al.
20140277412 September 18, 2014 Börtlein et al.
20140277418 September 18, 2014 Miller
20140277422 September 18, 2014 Ratz et al.
20140277427 September 18, 2014 Ratz et al.
20140296962 October 2, 2014 Cartledge et al.
20140296969 October 2, 2014 Tegels et al.
20140303649 October 9, 2014 Nguyen et al.
20140303720 October 9, 2014 Sugimoto et al.
20140309661 October 16, 2014 Sheps et al.
20140309730 October 16, 2014 Alon et al.
20140324164 October 30, 2014 Gross et al.
20140329225 November 6, 2014 Morin
20140331475 November 13, 2014 Duffy et al.
20140336744 November 13, 2014 Tani et al.
20140343668 November 20, 2014 Zipory et al.
20140343670 November 20, 2014 Bakis et al.
20140350662 November 27, 2014 Vaturi
20140350670 November 27, 2014 Keränen
20140358222 December 4, 2014 Gorman, III et al.
20140358224 December 4, 2014 Tegels et al.
20140378331 December 25, 2014 Morin
20140379006 December 25, 2014 Sutherland et al.
20140379065 December 25, 2014 Johnson et al.
20140379074 December 25, 2014 Spence et al.
20140379076 December 25, 2014 Vidlund et al.
20150012087 January 8, 2015 Miller et al.
20150018940 January 15, 2015 Quill et al.
20150018944 January 15, 2015 O'Connor et al.
20150032205 January 29, 2015 Matheny
20150045880 February 12, 2015 Hacohen
20150045881 February 12, 2015 Lim
20150051697 February 19, 2015 Spence et al.
20150081014 March 19, 2015 Gross et al.
20150094802 April 2, 2015 Buchbinder et al.
20150105855 April 16, 2015 Cabiri et al.
20150119970 April 30, 2015 Nakayama et al.
20150127097 May 7, 2015 Neumann et al.
20150142100 May 21, 2015 Morriss et al.
20150142103 May 21, 2015 Vidlund
20150148894 May 28, 2015 Damm et al.
20150157457 June 11, 2015 Hacohen
20150157458 June 11, 2015 Thambar et al.
20150164640 June 18, 2015 McLean et al.
20150173896 June 25, 2015 Richter et al.
20150173897 June 25, 2015 Raanani et al.
20150182336 July 2, 2015 Zipory et al.
20150196390 July 16, 2015 Ma et al.
20150196393 July 16, 2015 Vidlund et al.
20150216661 August 6, 2015 Hacohen et al.
20150230924 August 20, 2015 Miller et al.
20150238313 August 27, 2015 Spence et al.
20150245934 September 3, 2015 Lombardi et al.
20150250588 September 10, 2015 Yang et al.
20150272730 October 1, 2015 Melnick et al.
20150272731 October 1, 2015 Racchini et al.
20150272734 October 1, 2015 Sheps et al.
20150282964 October 8, 2015 Beard et al.
20150305903 October 29, 2015 Kitaoka
20150320556 November 12, 2015 Levi et al.
20150327994 November 19, 2015 Morriss et al.
20150328000 November 19, 2015 Ratz et al.
20150335429 November 26, 2015 Morriss et al.
20150342736 December 3, 2015 Rabito et al.
20150351903 December 10, 2015 Morriss et al.
20150351904 December 10, 2015 Cooper et al.
20150351906 December 10, 2015 Hammer et al.
20150359629 December 17, 2015 Ganesan et al.
20160030169 February 4, 2016 Shahriari
20160030171 February 4, 2016 Quijano et al.
20160089482 March 31, 2016 Siegenthaler
20160095700 April 7, 2016 Righini
20160100939 April 14, 2016 Armstrong et al.
20160106539 April 21, 2016 Buchbinder et al.
20160113766 April 28, 2016 Ganesan et al.
20160113768 April 28, 2016 Ganesan et al.
20160125160 May 5, 2016 Heneghan et al.
20160175095 June 23, 2016 Dienno et al.
20160200773 July 14, 2016 Morin
20160213473 July 28, 2016 Hacohen et al.
20160220367 August 4, 2016 Barrett
20160228247 August 11, 2016 Maimon et al.
20160242902 August 25, 2016 Morriss et al.
20160245802 August 25, 2016 Morin et al.
20160258939 September 8, 2016 Morin et al.
20160266089 September 15, 2016 Morin et al.
20160270911 September 22, 2016 Ganesan et al.
20160296330 October 13, 2016 Hacohen
20160310268 October 27, 2016 Oba et al.
20160310274 October 27, 2016 Gross et al.
20160317301 November 3, 2016 Quadri et al.
20160317305 November 3, 2016 Pelled et al.
20160324633 November 10, 2016 Gross et al.
20160324635 November 10, 2016 Vidlund et al.
20160324640 November 10, 2016 Gifford et al.
20160331526 November 17, 2016 Schweich et al.
20160331527 November 17, 2016 Vidlund et al.
20160338706 November 24, 2016 Rowe
20160367360 December 22, 2016 Cartledge et al.
20160367368 December 22, 2016 Vidlund et al.
20160374801 December 29, 2016 Jimenez et al.
20160374802 December 29, 2016 Levi et al.
20170042678 February 16, 2017 Ganesan et al.
20170049435 February 23, 2017 Sauer et al.
20170056166 March 2, 2017 Ratz et al.
20170056171 March 2, 2017 Cooper et al.
20170065407 March 9, 2017 Hacohen et al.
20170065411 March 9, 2017 Grundeman et al.
20170074855 March 16, 2017 Morin et al.
20170100236 April 13, 2017 Robertson et al.
20170128205 May 11, 2017 Tamir et al.
20170135816 May 18, 2017 Lashinski et al.
20170189174 July 6, 2017 Braido et al.
20170196688 July 13, 2017 Christianson et al.
20170196692 July 13, 2017 Kirk et al.
20170209264 July 27, 2017 Chau et al.
20170216026 August 3, 2017 Quill et al.
20170224323 August 10, 2017 Rowe et al.
20170231757 August 17, 2017 Gassler
20170231759 August 17, 2017 Geist et al.
20170231760 August 17, 2017 Lane et al.
20170231766 August 17, 2017 Hariton et al.
20170234850 August 17, 2017 Morin
20170239048 August 24, 2017 Goldfarb et al.
20170252159 September 7, 2017 Hacohen et al.
20170266003 September 21, 2017 Hammer et al.
20170333183 November 23, 2017 Backus
20170333187 November 23, 2017 Hariton et al.
20170349940 December 7, 2017 Morin et al.
20170360426 December 21, 2017 Hacohen et al.
20170367823 December 28, 2017 Hariton et al.
20180000580 January 4, 2018 Wallace et al.
20180014930 January 18, 2018 Hariton et al.
20180014932 January 18, 2018 Hammer et al.
20180021129 January 25, 2018 Peterson et al.
20180023114 January 25, 2018 Morin et al.
20180023115 January 25, 2018 Morin et al.
20180028215 February 1, 2018 Cohen
20180028311 February 1, 2018 Hacohen
20180049873 February 22, 2018 Manash et al.
20180055628 March 1, 2018 Patel et al.
20180055630 March 1, 2018 Patel et al.
20180098850 April 12, 2018 Rafiee et al.
20180116790 May 3, 2018 Ratz et al.
20180116843 May 3, 2018 Schreck et al.
20180125644 May 10, 2018 Conklin
20180132999 May 17, 2018 Perouse
20180147059 May 31, 2018 Hammer et al.
20180153687 June 7, 2018 Hariton et al.
20180153689 June 7, 2018 Maimon et al.
20180153696 June 7, 2018 Albitov et al.
20180161159 June 14, 2018 Lee et al.
20180177593 June 28, 2018 Hariton et al.
20180177594 June 28, 2018 Patel et al.
20180185148 July 5, 2018 Hariton et al.
20180206983 July 26, 2018 Noe et al.
20180214263 August 2, 2018 Rolando et al.
20180243086 August 30, 2018 Barbarino et al.
20180250126 September 6, 2018 O'connor et al.
20180250147 September 6, 2018 Syed
20180271654 September 27, 2018 Hariton et al.
20180280136 October 4, 2018 Hariton et al.
20180296333 October 18, 2018 Dixon et al.
20180296336 October 18, 2018 Cooper et al.
20180296341 October 18, 2018 Noe et al.
20180325671 November 15, 2018 Abunassar et al.
20180344457 December 6, 2018 Gross et al.
20180344490 December 6, 2018 Fox et al.
20180353294 December 13, 2018 Calomeni et al.
20180360457 December 20, 2018 Ellis et al.
20190000613 January 3, 2019 Delgado et al.
20190015200 January 17, 2019 Delgado et al.
20190021852 January 24, 2019 Delgado et al.
20190021857 January 24, 2019 Hacohen et al.
20190038404 February 7, 2019 Iamberger et al.
20190038405 February 7, 2019 Iamberger et al.
20190053896 February 21, 2019 Adamek-Bowers et al.
20190060060 February 28, 2019 Chau et al.
20190060068 February 28, 2019 Cope et al.
20190060070 February 28, 2019 Groothuis et al.
20190069997 March 7, 2019 Ratz et al.
20190069998 March 7, 2019 Hacohen
20190083248 March 21, 2019 Hariton et al.
20190083249 March 21, 2019 Hariton et al.
20190083261 March 21, 2019 Perszyk et al.
20190105153 April 11, 2019 Barash et al.
20190117391 April 25, 2019 Humair
20190167423 June 6, 2019 Hariton et al.
20190175339 June 13, 2019 Vidlund
20190175342 June 13, 2019 Hariton et al.
20190183639 June 20, 2019 Moore
20190192295 June 27, 2019 Spence et al.
20190216602 July 18, 2019 Lozonschi
20190231525 August 1, 2019 Hariton et al.
20190240010 August 8, 2019 Hacohen
20190336280 November 7, 2019 Naor
20190350701 November 21, 2019 Adamek-Bowers et al.
20190365530 December 5, 2019 Hoang et al.
20190388218 December 26, 2019 Vidlund et al.
20190388220 December 26, 2019 Vidlund et al.
20200000449 January 2, 2020 Goldfarb et al.
20200000579 January 2, 2020 Manash et al.
20200000580 January 2, 2020 Hacohen
20200015964 January 16, 2020 Noe et al.
20200030098 January 30, 2020 Delgado et al.
20200038181 February 6, 2020 Hariton et al.
20200046496 February 13, 2020 Hammer et al.
20200054335 February 20, 2020 Hernandez et al.
20200060818 February 27, 2020 Geist et al.
20200113677 April 16, 2020 McCann et al.
20200113689 April 16, 2020 McCann et al.
20200113692 April 16, 2020 McCann et al.
20200138567 May 7, 2020 Marr et al.
20200146824 May 14, 2020 Hammer et al.
20200163760 May 28, 2020 Hariton et al.
20200163761 May 28, 2020 Hariton et al.
20200205969 July 2, 2020 Hacohen
20200214832 July 9, 2020 Metchik et al.
20200237512 July 30, 2020 McCann et al.
20200246136 August 6, 2020 Marr et al.
20200246140 August 6, 2020 Hariton et al.
20200253600 August 13, 2020 Darabian
20200261094 August 20, 2020 Goldfarb et al.
20200306037 October 1, 2020 Siegel et al.
20200315786 October 8, 2020 Metchik et al.
20200337842 October 29, 2020 Metchik et al.
20200360139 November 19, 2020 Hammer et al.
20200390548 December 17, 2020 Hariton et al.
20210093449 April 1, 2021 Hariton et al.
20210106419 April 15, 2021 Abunassar
20210113331 April 22, 2021 Quadri et al.
20210137680 May 13, 2021 Kizuka et al.
20210259835 August 26, 2021 Tyler, II et al.
20220000612 January 6, 2022 Hacohen
Foreign Patent Documents
2822801 August 2006 CA
2671966 June 2008 CA
101653365 February 2010 CN
103974674 August 2014 CN
103997990 August 2014 CN
105324091 February 2016 CN
0170262 February 1986 EP
06/14342 September 1994 EP
10/06905 June 2000 EP
0954257 August 2000 EP
1258437 November 2002 EP
1264582 December 2002 EP
0871417 October 2003 EP
1266641 October 2004 EP
1034753 February 2005 EP
1258232 January 2006 EP
1637092 March 2006 EP
1990014 November 2008 EP
1562522 December 2008 EP
1420723 January 2009 EP
1903991 September 2009 EP
1418865 October 2009 EP
2119399 November 2009 EP
1531762 April 2010 EP
1450733 February 2011 EP
2446915 May 2012 EP
2088965 November 2012 EP
1768630 January 2015 EP
1861045 March 2015 EP
1465555 May 2015 EP
2349124 October 2018 EP
2739214 October 2018 EP
3417813 December 2018 EP
3583922 December 2019 EP
3270825 April 2020 EP
2485795 September 2020 EP
223448 December 2012 IL
S53152790 December 1978 JP
20010046894 June 2001 KR
2011/144351 November 2011 OA
92/05093 April 1992 WO
93/10714 June 1993 WO
96/39963 December 1996 WO
96/40344 December 1996 WO
97/01369 January 1997 WO
98/46149 October 1998 WO
1998/043557 October 1998 WO
1999/030647 June 1999 WO
00/22981 April 2000 WO
2000-047139 August 2000 WO
01/26586 April 2001 WO
01/56457 August 2001 WO
2001-062189 August 2001 WO
01/82832 November 2001 WO
02/085250 October 2002 WO
02/085251 October 2002 WO
02/085252 October 2002 WO
2003/020179 March 2003 WO
2003/028558 April 2003 WO
03/047467 June 2003 WO
2003/049647 June 2003 WO
2003/105667 December 2003 WO
2004/028399 April 2004 WO
04/103434 December 2004 WO
2004/108191 December 2004 WO
05/021063 March 2005 WO
05/046488 May 2005 WO
2005/062931 July 2005 WO
2005/107650 November 2005 WO
2006/007389 January 2006 WO
2006/007401 January 2006 WO
06/012013 February 2006 WO
06/012038 February 2006 WO
06/054930 May 2006 WO
2006/065212 June 2006 WO
2006/070372 July 2006 WO
06/086434 August 2006 WO
2006/089236 August 2006 WO
2006/091163 August 2006 WO
06/097931 September 2006 WO
06/105084 October 2006 WO
06/116558 November 2006 WO
2006/128193 November 2006 WO
07/011799 January 2007 WO
2007/030063 March 2007 WO
2007/047488 April 2007 WO
2007/059252 May 2007 WO
07/121314 October 2007 WO
07/136783 November 2007 WO
07/136981 November 2007 WO
08/013915 January 2008 WO
2008/014144 January 2008 WO
2008/029296 March 2008 WO
2008/031103 March 2008 WO
2008/058940 May 2008 WO
08/068756 June 2008 WO
2008/070797 June 2008 WO
2008/103722 August 2008 WO
2009/026563 February 2009 WO
09/033469 March 2009 WO
09/053497 April 2009 WO
2009/080801 July 2009 WO
2009/091509 July 2009 WO
2009/160631 October 2009 WO
10/004546 January 2010 WO
2010/000454 January 2010 WO
2010/006627 January 2010 WO
2010/006905 January 2010 WO
2010/027485 March 2010 WO
2010/037141 April 2010 WO
2010/044851 April 2010 WO
2010/045297 April 2010 WO
2010/057262 May 2010 WO
2010/073246 July 2010 WO
2010/081033 July 2010 WO
2010/085649 July 2010 WO
2010/121076 October 2010 WO
2010/128502 November 2010 WO
2010/128503 November 2010 WO
2010/150178 December 2010 WO
2011/025972 March 2011 WO
2011/051942 May 2011 WO
2011/067770 June 2011 WO
2011/069048 June 2011 WO
2011/089401 July 2011 WO
2011/089601 July 2011 WO
2011/106137 September 2011 WO
2011/111047 September 2011 WO
01/87190 November 2011 WO
2011/137531 November 2011 WO
2011-143263 November 2011 WO
2011/148374 December 2011 WO
2011/154942 December 2011 WO
2012/011108 January 2012 WO
2012/014201 February 2012 WO
2012/024428 February 2012 WO
2012/036740 March 2012 WO
2012/048035 April 2012 WO
2012/068541 May 2012 WO
2012/127309 September 2012 WO
2012/176195 December 2012 WO
2012/177942 December 2012 WO
2013/021374 February 2013 WO
2013/021375 February 2013 WO
2013/021384 February 2013 WO
2013/059747 April 2013 WO
2013/069019 May 2013 WO
2013/072496 May 2013 WO
2013/078497 June 2013 WO
2013/088327 June 2013 WO
2013/114214 August 2013 WO
2013/128436 September 2013 WO
2013/175468 November 2013 WO
2014/022124 February 2014 WO
2014/064694 May 2014 WO
2014/064695 May 2014 WO
2014/076696 May 2014 WO
2014/087402 June 2014 WO
2014/115149 July 2014 WO
2014/121280 August 2014 WO
2014/144937 September 2014 WO
2014/145338 September 2014 WO
2014/164364 October 2014 WO
2014/194178 December 2014 WO
2014/195786 December 2014 WO
2015/059699 April 2015 WO
2015/173794 November 2015 WO
2016/016899 February 2016 WO
2016/093877 June 2016 WO
2016/125160 August 2016 WO
2017/223486 December 2017 WO
2018/025260 February 2018 WO
2018/025263 February 2018 WO
2018/029680 February 2018 WO
2018/039631 March 2018 WO
2018/106837 June 2018 WO
2018/112429 June 2018 WO
2018/118717 June 2018 WO
2018/131042 July 2018 WO
2018/131043 July 2018 WO
2019/026059 February 2019 WO
2019/027507 February 2019 WO
2019/030753 February 2019 WO
2019/077595 April 2019 WO
2019/116369 June 2019 WO
2019/138400 July 2019 WO
2019/195860 October 2019 WO
2019/202579 October 2019 WO
2020/058972 March 2020 WO
2020/167677 August 2020 WO
2021/156866 August 2021 WO
2021/186424 September 2021 WO
Other references
  • An Office Action dated Nov. 25, 2021, which issued during the prosecution of European Patent Application No. 18826823.9.
  • IPR2021-01051 Institution decision dated Dec. 10, 2021.
  • Notice of Allowance dated Dec. 7, 2021, which issued during the prosecution of U.S. Appl. No. 17/394,807.
  • Notice of Allowance dated Dec. 6, 2021, which issued during the prosecution of U.S. Appl. No. 16/738,516.
  • Notice of Allowance dated Dec. 29, 2021, which issued during the prosecution of U.S. Appl. No. 17/210,183.
  • IPR2021-00383 Petitioners' Reply to Patent Owner's Response dated Jan. 5, 2022.
  • IPR2021-00383 Petitioners' Opposition to Patent Owner's Contingent Motion to Amend dated Jan. 5, 2022.
  • An Office Action dated Sep. 22, 2021, which issued during the prosecution of European Patent Application No. 20714289.4.
  • Summary of Examination Notice dated Jan. 6, 2022, which issued during the prosecution of Chinese Patent Application No. 201880064313.X.
  • An Office Action dated Jan. 12, 2022, which issued during the prosecution of U.S. Appl. No. 17/101,787.
  • Poirier, Nancy C., et al. “A novel repair for patients with atrioventricular septal defect requiring reoperation for left atrioventricular valve regurgitation.” European journal of cardio-thoracic surgery 18.1 (2000): 54-61.
  • An Office Action dated Mar. 29, 2021, which issued during the prosecution of U.S. Appl. No. 16/738,516.
  • Ando, Tomo, et al. “Iatrogenic ventricular septal defect following transcatheter aortic valve replacement: a systematic review.” Heart, Lung and Circulation 25.10 (2016): 968-974.
  • Urena, Marina, et al. “Transseptal transcatheter mitral valve replacement using balloon-expandable transcatheter heart valves: a step-by-step approach.” JACC: Cardiovascular Interventions 10.19 (2017): 1905-1919.
  • An English summary of an Official Action dated Mar. 29, 2021, which issued during the prosecution of Chinese Patent Application No. 201780061210.3.
  • An International Search Report and a Written Opinion both dated Jan. 28, 2020, which issued during the prosecution of Applicant's PCT/IL2019/051031.
  • An International Preliminary Report on Patentability dated Mar. 9, 2021, which issued during the prosecution of Applicant's PCT/IL2019/051031.
  • An Office Action dated May 4, 2021, which issued during the prosecution of U.S. Appl. No. 16/636,204.
  • Notice of Allowance dated May 17, 2021, which issued during the prosecution of U.S. Appl. No. 16/138,129.
  • Notice of Allowance dated Jun. 4, 2021, which issued during the prosecution of U.S. Appl. No. 16/802,353.
  • An Office Action dated May 12, 2021, which issued during the prosecution of Canadian Patent Application No. 2,973,940.
  • Petition for Inter Partes Review of U.S. Pat. No. 10,702,385—dated Jun. 4, 2021.
  • Declaration of Ivan Vesely, Ph.D. In Support of Petition for Inter Partes Review of U.S. Pat. No. 10,702,385—dated Jun. 4, 2021.
  • An Office Action dated Sep. 9, 2021, which issued during the prosecution of U.S. Appl. No. 16/768,909.
  • An Office Action dated Sep. 15, 2021, which issued during the prosecution of U.S. Appl. No. 16/135,599.
  • An Office Action dated Oct. 14. 2021, which issued during the prosecution of U.S. Appl. No. 16/680,739.
  • An Office Action dated Oct. 21, 2021, which issued during the prosecution of U.S. Appl. No. 17/335,845.
  • European Search Report dated Oct. 11, 2021 which issued during the prosecution of Applicant's European App No. 21176010.3.
  • Fann, James I., et al. “Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response.” Circulation 110.8 (2004): 988-993.
  • Feldman, Ted, et al. “Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort.” Journal of the American College of Cardiology 54.8 (2009): 686-694.
  • IPR2021-00383 Patent Owner's Contingent Motion To Amend Under 37 C.F.R. §42.121 dated Oct. 13, 2021.
  • IPR2021-00383 Patent Owner's Response Pursuant To 37 C.F.R. § 42.120 dated Oct. 13, 2021.
  • IPR2021-00383 Second Declaration of Dr. Michael Sacks dated Oct. 13, 2021.
  • An Office Action dated Oct. 21, 2021, which issued during the prosecution of U.S. Appl. No. 17/306,231.
  • Maisano, Francesco, et al. “The evolution from surgery to percutaneous mitral valve interventions: the role of the edge-to-edge technique.” Journal of the American College of Cardiology 58.21 (2011): 2174-2182.
  • IPR2021-00383 Deposition of DR. Ivan Vesely, dated Sep. 22, 2021.
  • Cardiovalve Exhibit 2009—Percutaneous Mitral Leaflet Repair: MitraClip® Therapy for Mitral Regurgitation (2012).
  • Feldman, Ted, et al. “Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial.” Journal of the American College of Cardiologv 46.11 (2005): 2134-2140.
  • An Office Action summarized English translation and Search Report dated Oct. 8, 2021, which issued during the prosecution of Chinese Patent Application No. 201780061210.3.
  • An Office Action dated Nov. 4, 2021, which issued during the prosecution of U.S. Appl. No. 17/366,711.
  • An Office Action summarized English translation and Search Report dated Aug. 12, 2021, which issued during the prosecution of Chinese Patent Application No. 201880058940.2.
  • IPR2021-00383 Decision Final Written Decision dated Jul. 18, 2022.
  • IPR2021-01051 Preliminary Guidance Patent Owner's Motion To Amend dated Jun. 24, 2022.
  • Ex Parte Quayle dated May 2, 2022, which issued during the prosecution of U.S. Appl. No. 16/879,952.
  • An International Search Report and a Written Opinion both dated May 3, 2022, which issued during the prosecution of Applicant's PCT/IL2021/051433.
  • An Office Action together with an English Summary dated May 7, 2022 which issued during the prosecution of Chinese Patent Application No. 201880058940.2.
  • Notice of Allowance dated May 4, 2022, which issued during the prosecution of U.S. Appl. No. 16/680,739.
  • An Office Action dated Jun. 28, 2022, which issued during the prosecution of U.S. Appl. No. 16/135,969.
  • An Office Action dated Jul. 8, 2022, which issued during the prosecution of U.S. Appl. No. 16/144,054.
  • An Office Action dated Jan. 26, 2022, which issued during the prosecution of U.S. Appl. No. 16/888,210.
  • Notice of Allowance dated Jan. 31, 2022, which issued during the prosecution of U.S. Appl. No. 17/479,418.
  • An Office Action dated Mar. 18, 2022, which issued during the prosecution of U.S. Appl. No. 16/746,489.
  • Notice of Allowance dated Mar. 22, 2022, which issued during the prosecution of U.S. Appl. No. 17/366,711.
  • Notice of Allowance dated Mar. 4, 2022, which issued during the prosecution of U.S. Appl. No. 16/768,909.
  • An Office Action dated Dec. 9, 2021, which issued during the prosecution of U.S. Appl. No. 16/135,969.
  • An Office Action dated Jan. 24, 2022, which issued during the prosecution of U.S. Appl. No. 16/135,466.
  • An Office Action dated Apr. 11, 2022, which issued during the prosecution of U.S. Appl. No. 17/473,472.
  • IPR2021-00383 Preliminary Guidance dated Jan. 31, 2022.
  • European Search Report dated Jun 10, 2021 which issued during the prosecution of Applicant's European App No. 21157988.3.
  • An Invitation to pay additional fees dated May 19, 2021, which issued during the prosecution of Applicant's PCT/IL2021/050132.
  • An International Search Report and a Written Opinion both dated Jul. 12, 2021, which issued during the prosecution of Applicant's PCT/IL2021/050132.
  • IPR2021-00383 Petitioners' Authorized Reply to Patent Owner's Preliminary Response dated May 27, 2021.
  • Exhibit 1014—Transcript of proceedings held May 20, 2021 (Edwards Lifesciences vs. Cardiovalve)
  • Exhibit 1015—Facilitate, Meriam-Webster.com, https://www.merriamwebster.com/dictionary/facilitate (visited May 26, 2021).
  • Patent Owner's Authorized Surreply to Petitioner's Reply to Patent Owner's Preliminary Response dated Jun. 4, 2021(Edwards Lifesciences vs. Cardiovalve).
  • An Office Action dated Aug. 18, 2021, which issued during the prosecution of U.S. Appl. No 17/210,183.
  • Institution decision dated Jul. 20, 2021(Edwards Lifesciences vs. Cardiovalve)
  • An Office Action dated Jul. 27, 2022, which issued during the prosecution of U.S. Appl. No. 16/881,350.
  • An Office Action dated Sep. 21, 2022, which issued during the prosecution of U.S. Appl. No. 16/776,581.
  • An Office Action dated Jul. 20, 2022, which issued during the prosecution of U.S. Appl. No. 17/101,787.
  • An Office Action dated Sep. 16, 2022, which issued during the prosecution of U.S. Appl. No. 16/135,466.
  • An Office Action dated Aug. 1, 2022, which issued during the prosecution of European Patent Application No. 18826823.9.
  • European Search Report dated Sep. 6, 2022 which issued during the prosecution of Applicant's European App No. 22161862.2.
  • IPR2021-01051 Petitioners' Reply To Preliminary Guidance dated Aug. 2, 2022.
  • IPR2021-01051 Patent Owner's Sur-Reply To Petitioners' Reply To Preliminary Guidance dated Aug. 23, 2022.
  • An Office Action dated Aug. 5, 2022, which issued during the prosecution of U.S. Appl. No. 16/760,147.
  • An Office Action dated Sep. 8, 2022, which issued during the prosecution of U.S. Appl. No. 16/896,858.
  • An Office Action dated Nov. 23, 2012, which issued during the prosecution of U.S. Appl. No. 13/033,852.
  • An Office Action dated Dec. 31, 2012, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An Office Action dated Feb. 6, 2013, which issued during the prosecution of U.S. Appl. No. 13/412,814.
  • Langer F et al., “RING plus STRING: Papillary muscle repositioning as an adjunctive repair technique for ischemic mitral regurgitation,” J Thorac Cardiovasc Surg 133:247-9, Jan. 2007.
  • Langer F et al., “RING+STRING: Successful repair technique for ischemic mitral regurgitation with severe leaflet tethering,” Circulation 120[suppl 1]: S85-S91, Sep. 2009.
  • “Transcatheter Valve-in-Valve Implantation for Failed Bioprosthetic Heart Valves”, J Webb et al., Circulation. Apr. 2010; 121: 1848-1857.
  • Jansen, J., Willeke, S., Reul, H. and Rum, G. (1992), Detachable Shape-Memory Sewing Ring for Heart Valves. Artificial Organs, 16:294-297. 1992 (an abstract).
  • Alexander S. Geha, et al., Replacement of degenerated mitral and aortic bioprostheses without explanation Ann Thorac Surg. Jun. 2001; 72:1509-1514.
  • An International Search Report and a Written Opinion both dated Oct. 13, 2011 which issued during the prosecution of Applicant's PCT/IL11/00231.
  • An Office Action dated Jul. 1, 2016, which issued during the prosecution of U.S. Appl. No. 14/161,921.
  • An International Search Report and a Written Opinion both dated Dec. 5, 2011, which issued during the prosecution of Applicant's PCT/IL11/00582.
  • An Office Action dated May 29, 2012, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • U.S. Appl. No. 61/555,160, filed Nov. 3, 2011.
  • U.S. Appl. No. 61/525,281, filed Aug. 19, 2011.
  • U.S. Appl. No. 61/537,276, filed Sep. 21, 2011.
  • U.S. Appl. No. 61/515,372, filed Aug. 5, 2011.
  • U.S. Appl. No. 61/492,449, filed Jun. 2, 2011.
  • U.S. Appl. No. 61/588,892, filed Jan. 20, 2012.
  • An International Search Report and a Written Opinion both dated Feb. 6, 2013, which issued during the prosecution of Applicant's PCT/IL12/00292.
  • An International Search Report and a Written Opinion both dated Feb. 6, 2013, which issued during the prosecution of Applicant's PCT/IL12/00293.
  • An Office Action dated Nov. 28, 2012, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • An Office Action dated Feb. 15, 2013, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • An Office Action dated Feb. 10, 2014, which issued during the prosecution of U.S. Appl. No. 13/031,852.
  • An Office Action dated Sep. 19, 2014, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An International Search Report and a Written Opinion both dated Sep. 4, 2014 which issued during the prosecution of Applicant's PCT/IL2014/050087.
  • Invitation to Pay Additional Fees dated Jun. 12, 2014 PCT/IL2014/050087.
  • An Office Action dated Jun. 17, 2014, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • An Office Action dated Jul. 3, 2014, which issued during the prosecution of U.S. Appl. No. 13/033,852.
  • An Office Action dated May 23, 2014, which issued during the prosecution of U.S. Appl. No. 13/411,814.
  • Dominique Himbert; Mitral Regurgitation and Stenosis from Bioprosthesis and Annuloplasty Failure: Transcatheter approaches and outcomes, 24 pages Oct. 28, 2013.
  • An International Search Report and a Written Opinion both dated Mar. 17, 2014 which issued during the prosecution of Applicant's PCT/IL2013/050937.
  • An International Preliminary Report on patentabilty dated Dec. 2, 2013, which issued during the prosecution of Applicant's PCT/IL11/00582.
  • An Office Action dated Sep. 12, 2013, which issued during the prosecution of U.S. Appl. No. 13/411,814.
  • An Office Action dated Aug. 2, 2013, which issued during the prosecution of U.S. Appl. No. 13/031,852.
  • An International Preliminary Report on patentabilty dated Sep. 11, 2012, which issued during the prosecution of Applicant's PCT/IL2011/000231.
  • An Office Action dated Jul. 2, 2014, which issued during the prosecution of U.S. Appl. No. 13/811,308.
  • An Office Action dated Jan. 20, 2016, which issued during the prosecution of U.S. Appl. No. 14/161,921.
  • An Office Action dated Jul. 23, 2013, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • An Office Action dated Jul. 18, 2013, which issued during the prosecution of U.S. Appl. No. 13/ 044,694.
  • An Office Action dated Nov. 8, 2013, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • An Office Action dated Jun. 4, 2014, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • An Office Action dated Aug. 13, 2012, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An Office Action dated Jul. 2, 2012, which issued during the prosecution of U.S. Appl. No. 13/033,852.
  • An Office Action dated Feb. 3, 2014, which issued during the prosecution of U.S. Appl. No. 13/811,308.
  • An International Preliminary Report on patentabilty dated Feb. 11, 2014, which issued during the prosecution of Applicant's PCT/IL12/00292.
  • An International Preliminary Report on patentabilty dated Feb. 11, 2014, which issued during the prosecution of Applicant's PCT/IL12/00293.
  • A Notice of Allowance dated Aug. 15, 2014, which issued during the prosecution of U.S. Appl. No. 13/411,814.
  • An Office Action dated Aug. 14, 2012, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • U.S. Appl. No. 61/283,819, filed Dec. 8, 2009.
  • Notice of Allowance dated Apr. 8, 2016, which issued during the prosecution of U.S. Appl. No. 14/237,258.
  • U.S. Appl. No. 61/756,034, filed Jan. 24, 2013.
  • U.S. Appl. No. 61/756,049, filed Jan. 24, 2013.
  • An International Preliminary Report on Patentability dated Jan. 31, 2017, which issued during the prosecution of Applicant's PCT/IL2015/050792.
  • U.S. Appl. No. 62/372,861, filed Aug. 10, 2016.
  • Notice of Allowance dated Aug. 13, 2018, which issued during the prosecution of U.S. Appl. No. 15/995,597.
  • Notice of Allowance dated Apr. 20, 2018, which issued during the prosecution of U.S. Appl. No. 15/878,206.
  • An Office Action dated Dec. 10, 2015, which issued during the prosecution of U.S. Appl. No. 14/237,258.
  • An International Preliminary Report on Patentability dated Jul. 28, 2015, which issued during the prosecution of Applicant's PCT/IL2014/050087.
  • An Office Action dated Nov. 27, 2015, which issued during the prosecution of U.S. Appl. No. 14/626,267.
  • An Office Action dated Jan. 21, 2016, which issued during the prosecution of U.S. Appl. No. 14/237,264.
  • An Office Action dated Jan. 30, 2015, which issued during the prosecution of UK Patent Application No. 1413474.6.
  • An International Search Report and a Written Opinion both dated May 30, 2016, which issued during the prosecution of Applicant's PCT/IL2016/050125.
  • An Office Action dated Sep. 26, 2016, which issued during the prosecution of U.S. Appl. No. 14/761,004.
  • An Office Action dated Jan. 18, 2017, which issued during the prosecution of U.S. Appl. No. 14/626,267.
  • An Office Action dated Feb. 7, 2017, which issued during the prosecution of U.S. Appl. No. 14/689,608.
  • An Office Action dated Feb. 8, 2017, which issued during the prosecution of UK Patent Application No. 1613219.3.
  • An Office Action together dated Feb. 10, 2017, which issued during the prosecution of European Patent Application No. 12821522.5.
  • An International Search Report and a Written Opinion both dated Oct. 27, 2015, which issued during the prosecution of Applicant's PCT/IL2015/050792.
  • European Search Report dated Feb. 18, 2015: which issued during the prosecution of Applicant's European App No. 12821522.5.
  • Saturn Project—a novel solution for transcatheter heart valve replacement specifically designed to address clinical therapeutic needs on mitral valve: Dec. 2016.
  • Righini presentation EuroPCR May 2015 (Saturn)—(downloaded from: https://www.pcronline.com/Cases-resourcesimages/Resources/Course-videos-slides/2015/Cardiovascularinnovation-pipeline-Mitral-and-tricuspid-valve-interventions).
  • An Advisory Action dated Apr. 2, 2018, which issued during the prosecution of U.S. Appl. No. 14/763,004.
  • An Office Action dated Jul. 26, 2018, which issued during the prosecution of U.S. Appl. No. 15/872,501.
  • An Office Action dated May 4, 2018, which issued during the prosecution of U.S. Appl. No. 15/872,501.
  • An Office Action dated Apr. 20, 2018, which issued during the prosecution of U.S. Appl. No. 15/886,517.
  • An Office Action dated Aug. 9, 2018, which issued during the prosecution of U.S. Appl. No. 15/899,858.
  • An Office Action dated Aug. 9, 2018, which issued during the prosecution of U.S. Appl. No. 15/902,403.
  • An Office Action dated Jun. 28, 2018, which issued during the prosecution of US Design U.S. Appl. No. 29/635,658.
  • An Office Action dated Jun. 28, 2018, which issued during the prosecution of US Design U.S. Appl. No. 29/635,661.
  • Georg Lutter, MD, et al; “Percutaneous Valve Replacement: Current State and Future Prospects”, The Annals of Thoracic Surgery ; vol. 78, pp. 2199-2206; Dec. 2004.
  • An Office Action dated Jun. 6, 2018, which issued during the prosecution of UK Patent Application No. 1720803.4.
  • An International Search Report and a Written Opinion both dated Jun. 20, 2018, which issued during the prosecution of Applicant's PCT/IL2018/050024.
  • An Office Action dated Jun. 18, 2018, which issued during the prosecution of UK Patent Appl. No. 1800399.6.
  • An Office Action dated Oct. 23, 2017, which issued during the prosecution of U.S. Appl. No. 14/763,004.
  • An Office Action dated Dec. 7, 2017, which issued during the prosecution of U.S. Appl. No. 15/213,791.
  • Interview Summary dated Feb. 8, 2018, which issued during the prosecution of U.S. Appl. No. 15/211,791.
  • An Office Action dated Feb. 7, 2018, which issued during the prosecution of U.S. Appl. No. 15/197,069.
  • An International Search Report and a Written Opinion both dated Nov. 24, 2017, which issued during the prosecution of Applicant's PCT/IL2017/050873.
  • An Office Action dated Jan. 5, 2018, which issued during the prosecution of U.S. Appl. No. 15/541,783.
  • An Office Action dated Feb. 2, 2018, which issued during the prosecution of U.S. Appl. No. 15/329,920.
  • An Invitation to pay additional fees dated Jan. 2, 2018, which issued during the prosecution of Applicant's PCT/IL2017/050849.
  • An Invitation to pay additional fees dated Sep. 29, 2017, which issued during the prosecution of Applicant's PCT/IL2017/050873.
  • European Search Report dated Jun. 29, 2017, which issued during the prosecution of Applicant's European App No. 11809374.9.
  • An Invitation to pay additional fees dated Oct. 11, 2018, which issued during the prosecution of Applicant's PCT/IL2018/050725.
  • An Office Action dated Dec. 4, 2018, which issued during the prosecution of U.S. Appl. No. 16/045,059.
  • An Office Action together with the English translation dated Nov. 5, 2018 which issued during the prosecution of Chinese Patent Application No. 201680008328.5.
  • Notice of Allowance dated Sep. 25, 2018, which issued during the prosecution of U.S. Appl. No. 15/188,507.
  • European Search Report dated Sep. 26, 2018 which issued during the prosecution of Applicant's European App No. 18186784.7.
  • An Office Action dated Jun. 30, 2015, which issued during the prosecution of U.S. Appl. No. 14/522,987.
  • Notice of Allowance dated Dec. 13, 2013, which issued during the prosecution of U.S. Appl. No. 13/675,119.
  • An International Preliminary Report on Patentability dated Aug. 8, 2017, which issued during the prosecution of Applicant's PCT/IL2016/050125.
  • An Office Action dated Jan. 17, 2018, which issued during the prosecution of U.S. Appl. No. 14/763,004.
  • An Office Action dated Mar. 25, 2015, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • An Office Action dated Feb. 25, 2016, which issued during the prosecution of U.S. Appl. No. 14/522,987.
  • An Office Action dated Apr. 13, 2016, which issued during the prosecution of U.S. Appl. No. 14/626,267.
  • An Office Action dated Aug. 28, 2015, which issued during the prosecution of U.S. Appl. No. 14/237,264.
  • Maisano (2015) TCR presentation re Cardiovalve.
  • Notice of Allowance dated Sep. 29, 2016, which issued during the prosecution of U.S. Appl. No. 14/442,541.
  • Notice of Allowance dated May 10, 2016, which issued during the prosecution of U.S. Appl. No. 14/237,258.
  • Notice of Allowance dated May 20, 2016, which issued during the prosecution of U.S. Appl. No. 14/237,258.
  • An International Preliminary Report on Patentability dated May 19, 2015, which issued during the prosecution of Applicant's PCT/IL2013/050937.
  • Dusan Pavcnik, MD, PhD2, et al; “Development and Initial Experimental Evaluation of a Prosthetic Aortic Valve for Transcatheter Placement”, Cardiovascular Radiology. Radiology Apr. 1992, vol. 183, pp. 151-154.
  • Notice of Allowance dated Oct. 16, 2013, which issued during the prosecution of U.S. Appl. No. 13/675,119.
  • Notice of Allowance dated Feb. 11, 2015, which issued during the prosecution of U.S. Appl. No. 13/033,852.
  • Notice of Allowance dated May 5, 2015, which issued during the prosecution of U.S. Appl. No. 12/840,463.
  • Notice of Allowance dated Mar. 10, 2015, which issued during the prosecution of U.S. Appl. No. 13/811,308.
  • Notice of Allowance dated Jul. 1, 2016, which issued during the prosecution of U.S. Appl. No. 14/442,541.
  • An Office Action dated Mar. 25, 2019, which issued during the prosecution of European Patent Application No. 14710060.6.
  • An International Search Report and a Written Opinion both dated Nov. 9, 2018, which issued during the prosecution of Applicant's PCT/IL2018/050869.
  • An International Search Report and a Written Opinion both dated Dec. 5, 2018, which issued during the prosecution of Applicant's PCT/IL2018/050725.
  • An International Search Report and a Written Opinion both dated Apr. 25, 2019, which issued during the prosecution of Applicant's PCT/IL2019/050142.
  • An International Preliminary Report on Patentability dated Feb. 12, 2019, which issued during the prosecution of Applicant's PCT/IL2017/050873.
  • An Office Action dated Sep. 13, 2019, which issued during the prosecution of U.S. Appl. No. 16/460,313.
  • An Office Action dated Nov. 26, 2019, which issued during the prosecution of U.S. Appl. No. 16/532,945.
  • An Office Action dated Aug. 16, 2019, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • An Office Action dated Nov. 1, 2019, which issued during the prosecution of U.S. Appl. No. 15/872,501.
  • An Office Action dated Jun. 14, 2019, which issued during the prosecution of U.S. Appl. No. 15/703,385.
  • An Office Action dated Oct. 4, 2019, which issued during the prosecution of U.S. Appl. No. 16/183,140.
  • An Office Action dated Jun. 13, 2019, which issued during the prosecution of U.S. Appl. No. 16/388,038.
  • An International Preliminary Report on Patentability dated Feb. 4, 2020, which issued during the prosecution of Applicant's PCT/IL2018/050725.
  • An International Search Report and a Written Opinion both dated Jan. 25, 2019, which issued during the prosecution of Applicant's PCT/IL2018/051122.
  • An International Search Report and a Written Opinion both dated May 13, 2019, which issued during the prosecution of Applicant's PCT/IL2018/051350.
  • An International Preliminary Report on Patentability dated Feb. 5, 2019, which issued during the prosecution of Applicant's PCT/IL2017/050849.
  • An Office Action dated Oct. 25, 2018, which issued during the prosecution of U.S. Appl. No. 14/763,004.
  • An Office Action dated Mar. 4, 2019, which issued during the prosecution of U.S. Appl. No. 14/763,004.
  • An Office Action dated Jan. 9, 2019, which issued during the prosecution of U.S. Appl. No. 15/329,920.
  • An Office Action dated Jan. 30, 2019, which issued during the prosecution of U.S. Appl. No. 15/872,501.
  • An Office Action dated Feb. 5, 2019, which issued during the prosecution of U.S. Appl. No. 15/899,858.
  • An Office Action dated May 23, 2019, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • An Office Action dated May 1, 2019, which issued during the prosecution of U.S. Appl. No. 15/691,032.
  • An Office Action dated Aug. 1, 2019, which issued during the prosecution of U.S. Appl. No. 15/668,559.
  • An Office Action dated Jun. 19, 2019, which issued during the prosecution of U.S. Appl. No. 15/682,789.
  • Notice of Allowance dated Jan. 13, 2020, which issued during the prosecution of U.S. Appl. No. 15/956,956.
  • An Office Action dated Jun. 25, 2019, which issued during the prosecution of U.S. Appl. No. 15/329,920.
  • An Office Action dated May 16, 2019, which issued during the prosecution of U.S. Appl. No. 15/433,547.
  • U.S. Appl. No. 62/560,384, filed Sep. 19, 2017.
  • U.S. Appl. No. 62/112,343, filed Feb. 5, 2015.
  • An International Preliminary Report on Patentability dated Feb. 11, 2020, which issued during the prosecution of Applicant's PCT/IL2018/050869.
  • An International Preliminary Report on Patentability dated Oct. 20, 2020, which issued during the prosecution of Applicant's PCT/IL2019/050142.
  • An Office Action dated Jan. 6, 2020, which issued during the prosecution of U.S. Appl. No. 16/660,231.
  • An Office Action dated Dec. 31, 2019, which issued during the prosecution of U.S. Appl. No. 16/183,140.
  • Notice of Allowance dated Apr. 24, 2019, which issued during the prosecution of U.S. Appl. No. 16/045,059.
  • An Office Action dated Jan. 14, 2020, which issued during the prosecution of U.S. Appl. No. 16/284,331.
  • European Search Report dated Mar. 5, 2020 which issued during the prosecution of Applicant's European App No. 17752184.6.
  • European Search Report dated Mar. 4, 2020 which issued during the prosecution of Applicant's European App No. 16706913.7.
  • Notice of Allowance dated Mar. 12, 2020, which issued during the prosecution of U.S. Appl. No. 16/460,313.
  • An Office Action dated Jan. 9, 2020, which issued during the prosecution of U.S. Appl. No. 15/600,190.
  • An Office Action dated Jan. 3, 2020, which issued during the prosecution of U.S. Appl. No. 16/678,355.
  • An Office Action dated Feb. 6, 2020, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • Notice of Allowance dated Nov. 26, 2019, which issued during the prosecution of U.S. Appl. No. 16/532,945.
  • Notice of Allowance dated Aug. 19, 2020, which issued during the prosecution of U.S. Appl. No. 16/637,166.
  • Notice of Allowance dated Jul. 27, 2020, which issued during the prosecution of U.S. Appl. No. 16/637,166.
  • Notice of Allowance dated Jun. 23, 2020, which issued during the prosecution of U.S. Appl. No. 16/637,166.
  • Notice of Allowance dated May 7, 2020, which issued during the prosecution of U.S. Appl. No. 16/637,166.
  • Sündermann, Simon H., et al. “Feasibility of the Engager™ aortic transcatheter valve system using a flexible over-the-wire design.” European Journal of Cardio-Thoracic Surgery 42.4 (2012): e48-e52.
  • An Office Action summarized English translation and Search Report dated Jul. 3, 2020, which issued during the prosecution of Chinese Patent Application No. 201780061210.3.
  • Serruys, P. W., Piazza, N., Cribier, A., Webb, J., Laborde, J. C., & de Jaegere, P. (Eds.). (2009). Transcatheter aortic valve implantation: tips and tricks to avoid failure. CRC Press.—Screenshots from Google Books downloaded from: https://books.google.co.il/books?id=FLzLBQAAQBAJ&lpg=PA198&ots=soqWrDH-y_&dq=%20%22Edwards%20SAPIEN%22&lr&pg=PA20#y=onepage&q=%22Edwards%20SAPIEN%22&f=false ; Downloaded on Jun. 18, 2020.
  • An International Search Report and a Written Opinion both dated Jun. 24, 2020, which issued during the prosecution of Applicant's PCT/IL2019/051398.
  • An Office Action dated Jul. 14, 2020, which issued during the prosecution of U.S. Appl. No. 16/324,339.
  • Notice of Allowance dated Aug. 28, 2020, which issued during the prosecution of U.S. Appl. No. 16/324,339.
  • Notice of Allowance dated Jul. 29, 2020, which issued during the prosecution of U.S. Appl. No. 16/132,937.
  • An Office Action dated Jul. 29, 2020, which issued during the prosecution of U.S. Appl. No. 16/269,328.
  • Notice of Allowance dated Aug. 26, 2020, which issued during the prosecution of U.S. Appl. No. 16/269,328.
  • An Office Action dated Aug. 7, 2020, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • Tchetche, D. and Nicolas M. Van Mieghem: “New-generation TAVI devices: description and specifications” EuroIntervention, 2014, No. 10:U90-U100.
  • An Office Action dated Aug. 23, 2019, which issued during the prosecution of U.S. Appl. No. 15/600,190.
  • Symetis S.A.: “ACURATE neo™ Aortic Bioprosthesis for Implantation using the ACURATE neo™ TA Transapical Delivery System in Patients with Severe Aortic Stenosis,” Clinical Investigation Plan, Protocol No. 2015-01, Vs. No. 2, 2015:1-76, Thomas Walther.
  • Notice of Allowance dated Sep. 10, 2020, which issued during the prosecution of U.S. Appl. No. 15/600,190.
  • Notice of Allowance dated Sep. 10, 2020, which issued during the prosecution of U.S. Appl. No. 16/324,339.
  • Notice of Allowance dated Oct. 19, 2020, which issued during the prosecution of U.S. Appl. No. 16/324,339.
  • Notice of Allowance dated Sep. 21, 2020, which issued during the prosecution of U.S. Appl. No. 16/269,328.
  • Notice of Allowance dated Oct. 28, 2020, which issued during the prosecution of U.S. Appl. No. 16/269,328.
  • Notice of Allowance dated Jan. 16, 2020, which issued during the prosecution of U.S. Appl. No. 15/872,501.
  • An Office Action dated May 11, 2020, which issued during the prosecution of U.S. Appl. No. 16/811,732.
  • An Office Action dated Sep. 24, 2020, which issued during the prosecution of U.S. Appl. No. 16/811,732.
  • Notice of Allowance dated Mar. 29, 2017, which issued during the prosecution of U.S. Appl. No. 14/161,921.
  • Agarwal et al. International Cardiology Perspective Functional Tricuspid Regurgitation, Circ Cardiovasc Interv 2009;2;2;565-573 (2009).
  • Alfieri et al., “An effective technique to correct anterior mitral leafet prolapse,” J Card 14(6):468-470. (1999).
  • Alfieri et al., “The double orifice technique in mitral valve repair: a simple solution for complex problems,” Journal of Thoracic Cardiovascular Surgery 122:674-681 (2001).
  • Alfieri, “The edge-to-edge repair of the mitral valve,” [Abstract] 6th Annual NewEra Cardiac Care: Innovation & Technology, Heart Surgery Forum pp. 103. (2000).
  • Alfieri et al. “Novel Suture Device for Beating-Heart Mitral Leaflet Approximation”, Ann Thorac Surg. 2002, 74:1488-1493.
  • Alfieri et al., “The edge to edge technique,” The European Association for Cardio-Thoracic Surgery 14th Annual Meeting Oct. 7-11, Book of Procees. (2000).
  • Amplatzer Cardiac Plug brochure (English pages), AGA Medical Corporation (Plymouth, MN) (copyright 2008-2010, downloaded Jan. 11, 2011).
  • AMPLATZER® Cribriform Occluder. A patient guide to Percutaneous, Transcatheter, Atrial Septal Defect Closuer, AGA Medical Corporation, Apr. 2008.
  • AMPLATZER® Septal Occluder. A patient guide to the Non-Surgical Closuer of the Atrial Septal Defect Using the AMPLATZER Septal Occluder System, AGA Medical Corporation, Apr. 2008.
  • Brennan, Jennifer, 510(k) Summary of safety and effectiveness, Jan. 2008.
  • Dictionary.com definition of “lock”, Jul. 29, 2013.
  • Dang NC et al. “Simplified Placement of Multiple Artificial Mitral Valve Chords,” The Heart Surgery Forum #2005-1005. 8 (3) (2005).
  • Maisano, The double-orifice technique as a standardized approach to treat mitral . . . , European Journal of Cardio-thoracic Surgery 17 (2000) 201-205.
  • “Two dimensional real-time ultrasonic imaging of the heart and great vessels”, Mayo Clin Proc. vol. 53:271-303, 1978.
  • Odell JA et al., “Early Results o4yf a Simplified Method of Mitral Valve Annuloplasty,” Circulation 92: 150-154 (1995).
  • O'Reilly S et al., “Heart valve surgery pushes the envelope,” Medtech Insight 8(3): 73, 99-108 (2006).
  • Swain CP et al., “An endoscopically deliverable tissue-transfixing device for securing biosensors in the gastrointestinal tract,” Gastrointestinal Endoscopy 40(6): 730-734 (1994).
  • An Invitation to pay additional fees dated Jan. 31, 2014, which issued during the prosecution of Applicant's PCT/IL2013/050860.
  • U.S. Appl. No. 62/030,715, filed Jul. 30, 2014.
  • U.S. Appl. No. 62/139,854, filed Mar. 30, 2015.
  • U.S. Appl. No. 61/312,412, filed Mar. 10, 2010.
  • An Invitation to pay additional fees dated Jan. 31, 2014, which issued during the prosecution of Applicant's PCT/IL2013/050861.
  • An International Preliminary Report on Patentability dated Dec. 23, 2013, which issued during the prosecution of Applicant's PCT/IL2012/000250.
  • An International Preliminary Report on Patentability dated Sep. 18, 2007, which issued during the prosecution of Applicant's PCT/IL2006/000342.
  • An International Preliminary Report on Patentability dated Jun. 5, 2012, which issued during the prosecution of Applicant's PCT/IL2010/001024.
  • An International Preliminary Report on Patentability dated Apr. 28, 2015, which issued during the prosecution of Applicant's PCT/IL2013/050861.
  • An International Preliminary Report on Patentability dated Apr. 26, 2016, which issued during the prosecution of Applicant's PCT/IL2014/050914.
  • An International Preliminary Report on Patentability dated Jun. 10, 2009, which issued during the prosecution of Applicant's PCT/IL07/01503.
  • An International Preliminary Report on Patentability dated Dec. 18, 2010, which issued during the prosecution of Applicant's PCT/IL09/00593.
  • An International Preliminary Report on Patentability dated Jun. 29, 2011, which issued during the prosecution of Applicant's PCT/IL2009/001209.
  • Notice of Allowance dated Aug. 18, 2017, which issued during the prosecution of U.S. Appl. No. 14/689,608.
  • Notice of Allowance dated Jul. 6, 2017, which issued during the prosecution of U.S. Appl. No. 14/682,608.
  • Notice of Allowance dated May 22, 2017, which issued during the prosecution of U.S. Appl. No. 14/689,608.
  • An Office Action dated Apr. 21, 2017, which issued during the prosecution of U.S. Appl. No. 15/213,791.
  • An Office Action dated Sep. 29, 2017, which issued during the prosecution of U.S. Appl. No. 15/191,069.
  • An International Preliminary Report on Patentability dated Nov. 9, 2011, which issued during the prosecution of Applicant's PCT/IL2010/000357.
  • An International Preliminary Report on Patentability dated Nov. 9, 2011 which issued during the prosecution of Applicant's PCT/IL2010/000358.
  • An International Preliminary Report on Patentability dated Nov. 27, 2012, which issued during the prosecution of Applicant's PCT/IL2011/000404.
  • An International Preliminary Report on Patentability dated Feb. 4, 2014, which issued during the prosecution of Applicant's PCT/IL2011/000446.
  • An International Preliminary Report on Patentability dated Jan. 29, 2013, which issued during the prosecution of Applicant's PCT/IL2011/000600.
  • An International Preliminary Report on Patentability dated Dec. 23, 2014, which issued during the prosecution of Applicant's PCT/IL2012/050451.
  • A Notice of Allowance dated Jul. 30, 2015, which issued during the prosecution of U.S. Appl. No. 13/319,007.
  • An Office Action dated Sep. 29, 2014, which issued during the prosecution of U.S. Appl. No. 13/504,370.
  • An Office Action dated Jan. 13, 2015, which issued during the prosecution of U.S. Appl. No. 13/707,013.
  • An Office Action dated Mar. 23, 2015, which issued during the prosecution of U.S. Appl. No. 13/707,013.
  • Notice of Allowance dated Mar. 25, 2015, which issued during the prosecution of U.S. Appl. No. 13/749,153.
  • An Office Action dated Oct. 3, 2014, which issued during the prosecution of U.S. Appl. No. 13/749,153.
  • Notice of Allowance dated May 22, 2015, which issued during the prosecution of U.S. Appl. No. 13/749,153.
  • Notice of Allowance dated Aug. 3, 2015, which issued during the prosecution of U.S. Appl. No. 13/749,153.
  • An Office Action dated Dec. 19, 2013, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • An Office Action dated Jun. 11, 2014, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • An Office Action dated Aug. 22, 2014, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • An Office Action dated Apr. 2, 2015, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • An Office Action dated Jan. 5, 2016, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • An Office Action dated Jan. 5, 2016, which issued during the prosecution of U.S. Appl. No. 14/084,426.
  • An Office Action dated Mar. 16, 2015, which issued during the prosecution of U.S. Appl. No. 14/084,426.
  • An Office Action dated Jan. 6, 2016, which issued during the prosecution of U.S. Appl. No. 14/128,756.
  • An Office Action dated May 11, 2016, which issued during the prosecution of U.S. Appl. No. 14/128,756.
  • Notice of Allowance dated Oct. 20, 2015, which issued during the prosecution of U.S. Appl. No. 12/996,954.
  • Notice of Allowance dated Feb. 19, 2014, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An Office Action dated Jul. 20, 2012, which issued during the prosecution of U.S. Appl. No. 12/843,412.
  • An Office Action dated Mar. 27, 2013, which issued during the prosecution of U.S. Appl. No. 12/841,412.
  • A Restriction Requirement dated May 1, 2012, which issued during the prosecution of U.S. Appl. No. 12/843,412.
  • A Notice of Allowance dated May 2, 2013, which issued during the prosecution U.S. Appl. No. 17/824,412.
  • A Restriction Requirement dated Nov. 19, 2012, which issued during the prosecution of U.S. Appl. No. 12/926,673.
  • An Office Action dated Feb. 12, 2013, which issued during the prosecution of U.S. Appl. No. 12/926,673.
  • An Office Action dated Oct. 22, 2013, which issued during the prosecution of U.S. Appl. No. 12/926,673.
  • A Notice of Allowance dated Jan. 7, 2014, which issued during the prosecution of U.S. Appl. No. 12/926,673.
  • An Office Action dated Oct. 9, 2013, which issued during the prosecution of U.S. Appl. No. 12/996,954.
  • An Office Action dated Mar. 24, 2015, which issued during the prosecution of U.S. Appl. No. 12/996,954.
  • An Office Action dated Oct. 5, 2012, which issued during the prosecution of U.S. Appl. No. 12/996,954.
  • Notice of Allowance dated Jul. 7, 2015, which issued during the prosecution of U.S. Appl. No. 12/996,954.
  • An Office Action dated Nov. 16, 2018, which issued during the prosecution of U.S. Appl. No. 16/042,028.
  • An International Search Report with Written Opinion both dated Feb. 2, 2012, which issued during the prosecution of Applicant's PCT/IL2011/000600.
  • An International Search Report together with Written Opinion both dated Mar. 30, 2011, which issued during the prosecution of Applicant's PCT/IL2010/001024.
  • An International Search Report and A Written Opinion both dated Feb. 10, 2011, which issued during the prosecution of Applicant's PCT/IL10/00890.
  • An Office Action dated May 28, 2015, which issued during the prosecution of U.S. Appl. No. 14/128,756.
  • An Office Action dated Sep. 6, 2018, which issued during the prosecution of U.S. Appl. No. 15/994,022.
  • An Office Action dated Sep. 7, 2018, which issued during the prosecution of U.S. Appl. No. 15/995,725.
  • An Office Action dated Nov. 26, 2018, which issued during the prosecution of U.S. Appl. No. 16/040,831.
  • An Office Action dated Jul. 11, 2018, which issued during the prosecution of U.S. Appl. No. 15/978,494.
  • An Office Action dated Nov. 23, 2018, which issued during the prosecution of U.S. Appl. No. 16/041,208.
  • An Office Action dated Jun. 15, 2018, which issued during the prosecution of U.S. Appl. No. 15/970,314.
  • An Office Action dated Oct. 12, 2018, which issued during the prosecution of U.S. Appl. No. 15/970,314.
  • An Office Action dated Jul. 26, 2018, which issued during the prosecution of U.S. Appl. No. 15/979,686.
  • An Office Action dated Sep. 10, 2018, which issued during the prosecution of U.S. Appl. No. 16/008,618.
  • An International Preliminary Report on Patentability dated Apr. 28, 2015, which issued during the prosecution of Applicant's PCT/IL2013/050860.
  • An Office Action dated Apr. 22, 2019, which issued during the prosecution of U.S. Appl. No. 15/668,559.
  • Notice of Allowance dated Aug. 30, 2019, which issued during the prosecution of U.S. Appl. No. 15/682,789.
  • Notice of Allowance dated Mar. 29, 2019, which issued during the prosecution of U.S. Appl. No. 15/541,783.
  • Dieter RS, “Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve,” Applications in Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003).
  • An Advisory Action dated Dec. 13, 2013, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • An Office Action dated August 7, 2015, which issued during the prosecution of U.S. Appl. No. 14/128,756.
  • An Office Action dated May 19, 2011, which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • An Office Action dated Sep. 1, 2011, which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • An Office Action dated May 30, 2012, which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • A Notice of Allowance dated Sep. 18, 2012, which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • Restriction Requirement dated May 5, 2011, which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • A Restriction Requirement dated Mar. 30, 2012, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • An Office Action dated Oct. 5, 2020, which issued during the prosecution of Canadian Patent Application No. 2,973,940.
  • An Office Action dated Nov. 30, 2020, which issued during the prosecution of U.S. Appl. No. 16/138,129.
  • An Office Action summarized English translation and Search Report dated Nov. 25, 2020, which issued during the prosecution of Chinese Patent Application No. 201910449820.1.
  • Notice of Allowance dated Nov. 19, 2020, which issued during the prosecution of U.S. Appl. No. 16/318,025.
  • An Office Action dated Aug. 2, 2011, which issued during the prosecution of U.S. Appl. No. 12/435,291.
  • Notice of Allowance dated Dec. 7, 2011, which issued during the prosecution of U.S. Appl. No. 12/435,291.
  • An Office Action dated Apr. 6, 2010, which issued during the prosecution of Applicant's U.S. Appl. No. 12/484,512.
  • An Office Action dated Oct. 6, 2010, which issued during the prosecution of Applicant's U.S. Appl. No. 12/484,512.
  • Notice of Allowance dated Apr. 20, 2011, which issued during the prosecution of U.S. Appl. No. 12/484,512.
  • Notice of Allowance dated Mar. 23, 2011, which issued during the prosecution of U.S. Appl. No. 12/484,512.
  • An Office Action dated Jan. 27, 2012, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • An Office Action dated Aug. 6, 2012, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • An Advisory Action dated Sep. 6, 2012 which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • Notice of Allowance dated Jun. 23, 2014, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • A Restriction Requirement dated Nov. 14, 2011 which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • Amendment, Terminal Disclaimer and Extension dated Jun. 27, 2012, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • A Restriction Requirement dated Jul. 5, 2012, which issued during the prosecution of U.S. Appl. No. 12/563,930.
  • An Office Action dated Apr. 2, 2013, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • An Office Action dated Dec. 27, 2013, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • An Office Action dated Nov. 5, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • An Office Action dated May 10, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • Notice of Allowance dated Nov. 13, 2014, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • Notice of Allowance dated Dec. 24, 2014, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • A Restriction Requirement dated Jan. 6, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • A Restriction Requirement dated Sep. 14, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An Office Action dated Aug. 15, 2013, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An Office Action dated Jan. 17, 2013, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • Notice of Allowance dated Nov. 19, 2013, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • A Notice of Allowance dated Jun. 26, 2012, which issued during the prosecution of U.S. Appl. No. 12/608,316.
  • An Office Action dated Nov. 14, 2011, which issued during the prosecution of U.S. Appl. No. 12/608,316.
  • A Restriction Requirement dated Apr. 1, 2011, which issued during the prosecution of U.S. Appl. No. 12/608,316.
  • An Office Action dated Jul. 6, 2012, which issued during the prosecution of U.S. Appl. No. 12/692,061.
  • An Office Action dated Jan. 23, 2012, which issued during the prosecution of U.S. Appl. No. 12/692,061.
  • An Office Action dated Mar. 9, 2012, which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • An Office Action dated Nov. 30, 2012, which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • A Notice of Allowance dated May 22, 2013, which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • Restriction Requirement dated Nov. 14, 2011, which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • An Office Action dated May 6, 2013, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • An Office Action dated Feb. 3, 2014, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • Notice of Allowance dated Jun. 11, 2014, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • A Restriction Requirement dated Sep. 17, 2012, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • A Notice of Allowance dated Sep. 3, 2014, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • European Search Report dated Jul. 8, 2016, which issued during the prosecution of Applicant's European App No. 13849843.1.
  • A Supplementary European Search Report dated Dec. 4, 2012, which issued during the prosecution of European Patent Application No. EP 09834225.6.
  • A Supplementary European Search Report dated Mar. 28, 2013, which issued during the prosecution of European Patent Application No. EP 1077 2091.4.
  • Search Report in European Patent Application 10772090.6 dated Jan. 17, 2014.
  • Supplementary European Search Report dated Oct. 23, 2014 which issued during the prosecution of Applicant's European App No. 10826224.7.
  • Notice of Allowance dated May 6, 2016, which issued during the prosecution of U.S. Appl. No. 14/667,090.
  • Notice of Allowance dated Apr. 12, 2016, which issued during the prosecution of U.S. Appl. No. 14/667,090.
  • An Office Action dated Jun. 7, 2013 which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • An Office Action dated Jun. 13, 2014, which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • Notice of Allowance dated Sep. 29, 2014, which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • An Office Action dated Feb. 4, 2013 which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • An English translation of an Office Action dated Apr. 23, 2014 which issued during the prosecution of Chinese Patent Application No. 201080059948.4.
  • Communication dated Jul. 25, 2014, issued by the State Intellectual Property Office of the P.R. of China in counterpart Application No. 200980157331.3.
  • An International Search Report and a Written Opinion both dated Jan. 25, 2016, which issued during the prosecution of Applicant's PCT/IL2015/051027.
  • An International Search Report dated May 19, 2011, which issued during the prosecution of Applicant's PCT/IL2011/00064.
  • An International Search Report and a Written Opinion both dated Feb. 22, 2013, which issued during the prosecution of Applicant's PCT/IL201/050451.
  • An International Search Report & Written Opinion both dated Mar. 21, 2014, which issued during the prosecution of Applicant's PCT/IL13/50992.
  • An International Search Report and Written Opinion both dated Apr. 9, 2014, which issued during the prosecution of Applicant's PCT/IL13/50860.
  • An International Search Report and a Written Opinion both dated Apr. 15, 2014, which issued during the prosecution of Applicant's PCT/IL2013/050861.
  • An International Search Report & Written Opinion both dated May 12, 2015, which issued during the prosecution of Applicant's PCT/IL2014/050914.
  • An International Search Report and a Written Opinion both dated May 30, 2007, which issued during the prosecution of Applicant's PCT/IL2006/000342.
  • An International Search Report and a Written Opinion both dated Jun. 10, 2010, which issued during the prosecution of Applicant's PCT/IL09/01209.
  • An International Search Report and a Written Opinion both dated Aug. 17, 2010, which issued during the prosecution of Applicant's PCT/IL10/00357.
  • An International Search Report & Written Opinion both dated Sep. 8, 2009, which issued during the prosecution of Applicant's PCT/IL09/00593.
  • An International Search Report and a Written Opinion both dated Sep. 12, 2008, which issued during the prosecution of Applicant's PCT/IL07/01503.
  • An International Search Report and Written Opinion dated Nov. 8, 2010, which issued during the prosecution of Applicant's PCT/IL2010/000358.
  • An International Search Report and a Written Opinion both dated Nov. 23, 2011, which issued during the prosecution of Applicant's PCT/IL2011/000446.
  • Supplementary European Search Report dated Sep. 25, 2015, which issued during the prosecution of Applicant's European App No. 09794095.1.
  • A Supplementary European Search Report dated Feb. 1, 2011, which issued during the prosecution of European Patent Application No. EP 07849540.
  • An English translation of an Office Action dated Dec. 12, 2013 which issued during the prosecution of Chinese Patent Application No. 200980157331.3.
  • Communication regarding amended claims filed dated Dec. 27, 2012, regarding European App No. 11792047.0.
  • An Office Action dated Mar. 23, 2015, which issued during the prosecution of European Patent Application No. EP 09834225.6.
  • An English translation of an Office Action dated Jul. 17, 2015 which issued during the prosecution of Chinese Patent Application No. 201080059948.4
  • An English translation of an Office Action dated Dec. 16, 2015 which issued during the prosecution of Chinese Patent Application No. 201080059948.4.
  • Communication from the European Patent Office dated Jun. 11, 2015, which issued during the prosecution of European Patent Application No. 11811934.
  • A communication from the European Patent Office dated Sep. 28, 2011 which issued during the prosecution of European Application No. 09834225.6.
  • A communication from the European Patent Office dated Oct. 19, 2012 which issued during the prosecution of European Application No. 11792047.0.
  • An Office Action dated Oct. 23, 2012: which issued during the prosecution of Japanese Patent Application No. 2009-539871.
  • An English Translation of an Office Action dated Nov. 24, 2015, which issued during the prosecution of Israel Patent Application No. 223448. (the relevant part only).
  • Notice of Allowance dated Nov. 17, 2015, which issued during the prosecution of U.S. Appl. No. 14/486,226.
  • Notice of Allowance dated Jan. 29, 2016, which issued during the prosecution of U.S. Appl. No. 14/551,951.
  • An Office Action dated Jun. 18, 2015, which issued during the prosecution of U.S. Appl. No. 14/551,951.
  • An Office Action dated Jan. 4, 2016, which issued during the prosecution of U.S. Appl. No. 14/589,100.
  • An Office Action dated May 4, 2016, which issued during the prosecution of U.S. Appl. No. 14/589,100.
  • An International Search Report and a Written Opinion both dated Nov. 14, 2011, which issued during the prosecution of Applicant's PCT/IL2011/000404.
  • An International Search Report and a Written Opinion both dated Dec. 6, 2012 which issued during the prosecution of Applicant's PCT/IL2012/000250.
  • A Notice of Allowance dated Apr. 3, 2013, which issued during the prosecution of U.S. Appl. No. 12/563,930.
  • An Office Action dated Aug. 24, 2012, which issued during the prosecution of U.S. Appl. No. 12/563,930.
  • An Office Action dated Dec. 29, 2011, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • A Restriction Requirement dated Oct. 27, 2011, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • A Notice of Allowance dated May 24, 2012, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • An Office Action dated Apr. 1, 2013 which issued during the prosecution of U.S. Appl. No. 13/167,2476.
  • An Office Action dated Nov. 21, 2013, which issued during the prosecution of U.S. Appl. No. 13/161,476.
  • An Advisory Action dated Feb. 4, 2014, which issued during the prosecution of U.S. Appl. No. 13/161,476.
  • A Restriction Requirement dated Oct. 25, 2012 which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • An Office Action dated Jan. 17, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • An Office Action dated Aug. 26, 2014 which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • An Office Action dated Aug. 23, 2013 which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • Notice of Allowance dated Nov. 12, 2015, which issued during the prosecution of U.S. Appl No. 13/319,007.
  • Notice of Allowance dated Jan. 7, 2016, which issued during the prosecution of U.S. Appl. No. 13/319,007.
  • An Office Action dated Oct. 2, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,492.
  • A Restriction Requirement dated Nov. 2, 2012, which issued during the prosecution of U.S. Appl. No. 13/161,492.
  • An Office Action dated Feb. 14, 2013 which issued during the prosecution of U.S. Appl. No. 13/167,492.
  • Notice of Allowance dated Nov. 7, 2014, which issued during the prosecution of U.S. Appl. No. 13/161,492.
  • An Office Action dated Jun. 10, 2014, which issued during the prosecution of U.S. Appl. No. 13/161,492.
  • Notice of Allowance dated Dec. 9, 2014, which issued during the prosecution of U.S. Appl. No. 13/161,476.
  • Notice of Allowance dated Jan. 22, 2015, which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • An International Preliminary Report on Patentability dated May 1, 2012, which issued during the prosecution of Applicant's PCT/IL2010/000890.
  • An International Preliminary Report on Patentability dated Jun 9, 2015, which issued during the prosecution of Applicant's PCT/IL2013/050992.
  • U.S. Appl. No. 60/873,075, filed Dec. 5, 2006.
  • U.S. Appl. No. 60/902,146, filed Feb. 16, 2007.
  • An Office Action dated Mar. 29, 2018, which issued during the prosecution of U.S. Appl. No. 15/188,507.
  • Notice of Allowance dated Sep. 17, 2014, which issued during the prosecution of U.S. Appl. No. 12/961,721.
  • An Office Action dated Oct. 1, 2015, which issued during the prosecution of U.S. Appl. No. 14/141,228.
  • A Restriction Requirement dated Jun. 2, 2014, which issued during the prosecution of U.S. Appl. No. 13/319,030.
  • An Office Action dated Oct. 14, 2014, which issued during the prosecution of U.S. Appl. No. 13/319,030.
  • An Office Action dated Jun. 18, 2015, which issued during the prosecution of U.S. Appl. No. 13/319,030.
  • An Office Action dated May 3, 2016, which issued during the prosecution of U.S. Appl. No. 13/319,030.
  • Notice of Allowance dated Dec. 30, 2016, which issued during the prosecution of U.S. Appl. No. 13/319,030.
  • An Office Action dated Apr. 7, 2015, which issued during the prosecution of U.S. Appl. No. 13/319,007.
  • An Office Action dated April 8, 2016, which issued during the prosecution of U.S. Appl. No. 14/141,228.
  • An Office Action dated Oct. 5, 2015, which issued during the prosecution of U.S. Appl. No. 14/246,417.
  • An Office Action dated April 7, 2016, which issued during the prosecution of U.S. Appl. No. 14/242,151.
  • An Office Action dated May 23, 2016, which issued during the prosecution of U.S. Appl. No. 14/209,171.
  • An Office Action dated Jul. 20, 2016, which issued during the prosecution of U.S. Appl. No. 14/246,417.
  • An Office Action dated Jun, 14, 2016, which issued during the prosecution of U.S. Appl. No. 14/273,155.
  • An Office Action dated Jun. 17, 2016, which issued during the prosecution of U.S. Appl. No. 14/357,040.
  • An Office Action dated Mar. 24, 2015, which issued during the prosecution of U.S. Appl. No. 14/486,226.
  • U.S. Appl. No. 61/001,013, filed Oct. 29, 2007.
  • U.S. Appl. No. 61/132,295, filed Jun. 16, 2008.
  • U.S. Appl. No. 61/265,936, filed Dec. 2, 2009.
  • U.S. Appl. No. 61/283,445, filed Dec. 2, 2009.
  • U.S. Appl. No. 61/207,908, filed Feb. 17, 2009.
  • U.S. Appl. No. 61/733,979, filed Dec. 6, 2012.
  • U.S. Appl. No. 61/717,303, filed Oct. 23, 2012.
  • U.S. Appl. No. 61/820,979, filed May 8, 2013.
  • U.S. Appl. No. 61/745,848, filed Dec. 6, 2012.
  • U.S. Appl. No. 61/555,570, filed Nov. 4, 2011.
  • U.S. Appl. No. 61/557,082, filed Nov. 8, 2011.
  • U.S. Appl. No. 60/662,616, filed Mar. 17, 2005.
  • U.S. Appl. No. 60/700,542, filed Jul. 18, 2005.
  • U.S. Appl. No. 61/782,121, filed Mar. 14, 2013.
  • European Search Report dated Jul. 15, 2016, which issued during the prosecution of Applicant's European App No. 13849947.0.
  • European Search Report dated Nov. 4, 2015, which issued during the prosecution of European Patent Application No. EP 1077 2091.4.
  • Search Report in European Patent Application 10826224.7 dated Nov. 16, 2015.
  • Supplementary European Search Report dated Dec. 23, 2014 which issued during the prosecution of Applicant's European App No. 10834311.
  • Supplementary European Search Report dated Jan. 21, 2014 which issued during the prosecution of Applicant's European App No. 11 78 6226.
  • A Supplementary European Search Report dated Jan. 20, 2015, which issued during the prosecution of European Patent Application No. 12803037.6.
  • Supplementary European Search Report dated Aug. 4, 2014 which issued during the prosecution of Applicant's European App No. 11 81 1934.6.
  • European Search Report dated Jun. 24, 2016, which issued during the prosecution of European Patent Application No. EP 12847363.
  • Supplementary European Search Report dated Apr. 29, 2015, which issued during the prosecution of Applicant's European App No. 14200202.
  • An Office Action dated Dec. 16, 2013, which issued during the prosecution of U.S. Appl. No. 13/666,262.
  • An Office Action dated Dec. 18, 2013, which issued during the prosecution of U.S. Appl. No. 13/666,141.
  • Notice of Allowance dated Jun. 25, 2014, which issued during the prosecution of U.S. Appl. No. 13/666,262.
  • A Notice of Allowance dated Feb. 2, 2015, which issued during the prosecution of U.S. Appl. No. 13/504,870.
  • Notice of Allowance dated Aug. 19, 2013, which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • An Office Action dated Jun. 8, 2012, which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • An Office Action dated Dec. 21, 2012, which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • A Restriction Requirement dated Aug. 5, 2011, which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • An Office Action dated Sep. 16, 2009 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • Notice of Allowance dated Sep. 12, 2014, which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • An Office Action dated Aug. 5, 2010 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • An Office Action dated Feb. 17, 2010 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • A Restriction Requirement dated Apr. 19, 2010 which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Office Action dated Sep. 28, 2011, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • An Office Action dated Jun. 13, 2012, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • A Restriction Requirement dated Jul. 12, 2011, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • Notice of Allowance dated Mar. 6, 2014, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • Notice of Allowance dated Dec. 20, 2013, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • Notice of Allowance dated Apr. 27, 2012, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Office Action dated Mar. 29, 2011, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Office Action dated Aug. 4, 2010, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Interview Summary dated Jul. 27, 2011, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • Notice of Allowance dated Aug. 21, 2019, which issued during the prosecution of U.S. Appl. No. 15/703,385.
  • Notice of Allowance dated Oct. 16, 2019, which issued during the prosecution of U.S. Appl. No. 15/703,385.
  • Notice of Allowance dated Dec. 24, 2020, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • Notice of Allowance dated Oct. 21, 2020, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • Declaration of Ivan Vesely, Ph.D., in Support of Petition for Inter Partesreview of U.S. Pat. No. 7,563,267—dated May 29, 2019.
  • U.S. Appl. No. 60/128,690, filed Apr. 9, 1999.
  • U.S. Appl. No. 60/613,867, filed Sep. 27, 2004.
  • An Office Action dated Dec. 24, 2020, which issued during the prosecution of U.S. Appl. No. 16/144,054.
  • An Office Action dated Feb. 2, 2021, which issued during the prosecution of U.S. Appl. No. 16/811,732.
  • An Office Action dated Jan. 13, 2021, which issued during the prosecution of European Patent Application No. 15751089.2.
  • An Office Action together with an English summary dated Mar. 3, 2021, which issued during the prosecution of Chinese Patent Application No. 201780047391.4.
  • Declaration of Dr. Ivan Vesely, Ph.D. in Support of Petition for Inter Partes Review of U.S. Pat. No. 10,226,341—dated Dec. 17, 2020.
  • Petition for Inter Partes Review of U.S. Pat. No. 10,226,341 and Exhibits 1001-1013—dated Dec. 29, 2020.
  • Batista, Randas JV, et al. “Partial left ventriculectomy to treat end-stage heart disease.” The Annals of thoracic surgery 64.3 (1997): 634-638.
  • Beall Jr, Arthur C., et al. “Clinical experience with a dacron velour-covered teflon-disc mitral-valve prosthesis.” The Annals of thoracic surgery 5.5 (1968): 402-410.
  • Kalbacher, D., et al. “1000 MitraClip™ procedures: Lessons learnt from the largest single-centre experience worldwide.” (2019): 3137-3139.
  • Maisano, F., et al. “The edge-to-edge technique: a simplified method to correct mitral insufficiency.” European journal of cardio-thoracic surgery 13.3 (1998): 240-246.
  • Fucci, C., et al. “Improved results with mitral valve repair using new surgical techniques.” European journal of cardio-thoracic surgery 9.11 (1995): 621-627.
  • Notice of Allowance dated Nov. 19, 2019, which issued during the prosecution of U.S. Appl. No. 15/668,559.
  • Mitral Valve Academic Research Consortium. “Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles A Consensus Document from the Mitral Valve Academic Research Consortium.” Journal of the American College of Cardiology 66.3 (2015): 278-307.
  • An Office Action dated Aug. 29, 2018, which issued during the prosecution of U.S. Appl. No. 15/329,920.
  • An Office Action dated May 8, 2018, which issued during the prosecution of U.S. Appl. No. 15/902,403.
  • An Office Action dated May 11, 2018, which issued during the prosecution of U.S. Appl. No. 15/899,858.
  • Notice of Allowance dated Oct. 5, 2018, which issued during the prosecution of U.S. Appl. No. 15/886,517.
  • Notice of Allowance dated Jul. 19, 2019, which issued during the prosecution of U.S. Appl. No. 15/899,858.
  • Notice of Allowance dated Nov. 16, 2020, which issued during the prosecution of U.S. Appl. No. 16/324,339.
  • Notice of Allowance dated Apr. 27, 2020, which issued during the prosecution of U.S. Appl. No. 16/591,330.
  • An Advisory Action dated Jan. 2, 2020, which issued during the prosecution of U.S. Appl. No. 15/668,659.
  • Notice of Allowance dated Oct. 17, 2019, which issued during the prosecution of U.S. Appl. No. 15/329,920.
  • An Office Action dated Dec. 31, 2019, which issued during the prosecution of U.S. Appl. No. 16/591,330.
  • Notice of Allowance dated Feb. 9, 2021, which issued during the prosecution of U.S. Appl. No. 16/937,216.
  • An Office Action dated Sep. 29, 2022, which issued during the prosecution of U.S. Appl. No. 17/010,886.
  • An Office Action dated Sep. 29, 2022, which issued during the prosecution of U.S. Appl. No. 16/656,790.
  • An Office Action dated Nov. 2, 2022, which issued during the prosecution of U.S. Appl. No. 17/004,693.
  • An Office Action dated Oct. 19, 2022, which issued during the prosecution of U.S. Appl. No. 17/875,589.
  • An Office Action dated Oct. 26, 2022, which issued during the prosecution of U.S. Appl. No. 16/746,489.
  • An Office Action dated Mar. 3, 2023, which issued during the prosecution of European Patent Application No. 17751143.3.
  • An Office Action dated Mar. 20, 2023, which issued during the prosecution of U.S. Appl. No. 17/181,722.
  • European Search Report dated Mar. 20, 2023 which issued during the prosecution of Applicant's European App No. 22204764.9.
  • Notice of Allowance dated Apr. 6, 2023, which issued during the prosecution of U.S. Appl. No. 16/746,489.
  • An Office Action dated Apr. 14, 2023, which issued during the prosecution of U.S. Appl. No. 16/144,054.
  • An Office Action dated May 15, 2023, which issued during the prosecution of U.S. Appl. No. 16/656,790.
  • An Office Action dated May 16, 2023, which issued during the prosecution of U.S. Appl. No. 17/114,771.
  • An Office Action dated May 17, 2023, which issued during the prosecution of U.S. Appl. No. 17/466,785.
  • An Office Action dated May 25, 2023, which issued during the prosecution of U.S. Appl. No. 17/397,235.
Patent History
Patent number: 11801135
Type: Grant
Filed: Jan 5, 2021
Date of Patent: Oct 31, 2023
Patent Publication Number: 20210145578
Assignee: CARDIOVALVE LTD. (Or Yehuda)
Inventors: Ilia Hariton (Zichron Yaackov), Boaz Harari (Ganey Tikva), Maxim Karalnik (Karmiel), Meni Iamberger (Kfar Saba)
Primary Examiner: Tuan V Nguyen
Application Number: 17/141,853
Classifications
Current U.S. Class: Cardiovascular (600/481)
International Classification: A61F 2/24 (20060101); A61F 2/95 (20130101); A61F 2/915 (20130101);